The impact of social media presence,age, and patient reported wait times on physician review websites for sports medicine surgeons

BackgroundWhen choosing physicians, patients often review options online via physician review websites, which may influence decisions on providers.PurposeThe purpose of this study is to investigate the impacts of social media usage, age, and patient reported wait times on online ratings for three popular review websites.Study designCross-sectional study.MethodsThe American Orthopaedic Society for Sports Medicine database was used to extract demographic information for all listed sports medicine surgeons in Florida. Overall ratings, number of ratings and comments, and patient reported wait-times were recorded from three leading review websites (Healthgrades.com, Vitals.com, Google.com). Professionally focused SM accounts were searched for each physician on Facebook.com, Twitter.com, Instagram, and LinkedIn.com.Results102 orthopaedic sports medicine surgeons were included. At least one form of social media was used by 62.4% of our cohort. Those with social media had higher overall online physician ratings out of 5.00 across all review websites (Google:4.65vs4.44, p = 0.05; Healthgrades:4.41vs4.15, p = 0.03; Vitals:4.43vs4.14, p = 0.01). In bivariate analysis, older age was associated with lower ratings on Health Grades (Absolute difference (AD) −0.26, p < 0.0001), and social media was linked to higher ratings (Google: AD 0.21, p = 0.05; Healthgrades: AD 0.26, p = 0.03; Vitals: AD 0.29, p = 0.008). Longer wait times were associated with lower ratings in a dose-dependent manner in both bivariate and multivariable analysis.ConclusionsSocial media use among sports medicine surgeons correlated with higher overall physician ratings. Potentially, younger surgeons increase social media use because of a heightened concern for online image, whereas older surgeons may have less value in using online platforms to capitalize on an online presence. Older age and increased patient reported wait times in office had a negative correlation with online reviews, which highlights that factors beyond the surgeon's skill sets can influence overall ratings.     

Intraoperative hypotension is not associated with postoperative cognitive dysfunction in elderly patients undergoing general anesthesia for surgery: results of a randomized controlled pilot trial

Study objectiveTo assess the effect of different intraoperative blood pressure targets on the development of POCD and test the feasibility of a larger trial.DesignRandomized controlled pilot trial.SettingPerioperative care in a tertiary care teaching hospital with outpatient follow-up.PatientsOne hundred one patients aged ≥75 years with ASA physical status <4, undergoing elective, non-cardiac surgery under general anesthesia and 33 age-matched healthy controls.InterventionsRandomization to a personalized intraoperative blood pressure target, mean arterial pressure (MAP) ≥ 90% of preoperative values (Target group), or to a more liberal intraoperative blood pressure management (No-Target group). Strategies to reach intraoperative blood pressure target were at discretion of anesthesiologists.MeasurementsAn experienced neuropsychologist performed a validated battery of neurocognitive tests preoperatively and 3 months after surgery. Incidence of POCD at three months and postoperative delirium were assessed. Intraoperative time spent with MAP ≥ 90% of preoperative values, recruitment and drop-out rate at 3 months were feasibility outcomes.Main resultsThe Target group spent a higher percentage of intraoperative time with MAP ≥90% of preoperative values (65 ± 25% vs. 49 ± 28%, p < 0.01). Incidence of POCD (11% vs. 7%, relative risk 1.52; 95% CI, 0.41 to 6.3; p = 0.56) and delirium (6% vs. 14%, relative risk, 0.44; 95% CI, 0.12 to 1.60; p = 0.21) did not differ between groups. No correlation was found between intraoperative hypotension and postoperative cognitive performance (p = 0.75) or delirium (p = 0.19). Recruitment rate was of 6 patients/month (95% confidential interval (CI), 5 to 7) and drop-out rate at 3 months was 24% (95% CI, 14 to 33%).ConclusionsIntraoperative hypotension did not correlate with postoperative cognitive dysfunction or delirium occurrence in elderly patients undergoing general anesthesia for non-cardiac surgery.A multicenter randomized controlled trial is needed in order to confirm the effect of intraoperative blood pressure on the development of POCD.Trial registration numberNCT02428062 www.clinicaltrials.gov.     

Perioperative supplemental oxygen and oxidative stress in patients undergoing moderate- to high-risk major abdominal surgery – A subanalysis of randomized clinical trial

Study objectiveOxidative stress plays a pivotal role in the development and aggravation of cardiovascular diseases. The influence of intraoperative inspired oxygen concentrations on oxidative stress is still not entirely known. Therefore, we evaluated in this sub-study if supplemental oxygen affects the oxidation-reduction potential in patients at-risk for cardiovascular complications undergoing moderate- to high-risk major abdominal surgery.DesignSub-study of a prospective parallel-arm double-blinded single-center superiority randomized trial.SettingOperating room and postoperative recovery area.InterventionAdministration of 0.8 FiO₂ versus 0.3 FiO₂ throughout surgery and for the first two postoperative hours.MeasurementsThe primary outcome was the static oxidation-reduction potential (sORP) and the oxidation-reduction potential capacity (cORP) between both groups. The secondary outcome was the trend of sORP and cORP in the overall study population. We assessed sORP and cORP before induction of anesthesia, 2 h after induction of anesthesia, within 2 h after surgery and on the first and third postoperative day.Main results258 patients were analyzed. 128 patients were randomly assigned to the 80% oxygen group and 130 patients were randomly assigned to the 30% oxygen group. Postoperative sORP values did not differ significantly between the 80% and 30% oxygen group (effect estimate: −1.162 mV,95% CI: −2.584 to 0.260; p = 0.109). On average, we observed a change in sORP of 5.288 mV (95% CI:4.633 to 5.913, p < 0.001) per day. cORP values did not differ significantly between the 80% and 30% oxygen group (effect estimate: −0.015μC, (95%CI: −0.062 to 0.032; p = 0.524). On average, we observed a change in cORP values of −0.170μC (95%CI: −0.194 to −0.147, p < 0.001) per day.ConclusionIn contrast to previous reports, we could not find any evidence of an association between intraoperative supplemental oxygen and perioperative oxidative stress assessed by sORP and cORP.Trial registrationclinicaltrials.gov: NCT03366857 https://clinicaltrials.gov/ct2/show/NCT03366857?term=vienna&cond=oxygen&draw=2&rank=1     

A multicenter study to evaluate the pharmacokinetics and safety of liposomal bupivacaine for postsurgical analgesia in pediatric patients aged 6 to less than 17 years (PLAY)

Study objectiveTo evaluate the pharmacokinetics and safety of liposomal bupivacaine in pediatric patients undergoing spine or cardiac surgery.DesignMulticenter, open-label, phase 3, randomized trial (PLAY; NCT03682302).SettingOperating room.PatientsTwo separate age groups were evaluated (age group 1: patients 12 to <17 years undergoing spine surgery; age group 2: patients 6 to <12 years undergoing spine or cardiac surgery).InterventionRandomized allocation of liposomal bupivacaine 4 mg/kg or bupivacaine hydrochloride (HCl) 2 mg/kg via local infiltration at the end of spine surgery (age group 1); liposomal bupivacaine 4 mg/kg via local infiltration at the end of spine or cardiac surgery (age group 2).MeasurementsThe primary and secondary objectives were to evaluate the pharmacokinetics (eg, maximum plasma bupivacaine concentrations [C_max], time to C_max) and safety of liposomal bupivacaine, respectively.Main resultsBaseline characteristics were comparable across groups. Mean C_max after liposomal bupivacaine administration was lower versus bupivacaine HCl in age group 1 (357 vs 564 ng/mL); mean C_max in age group 2 was 320 and 447 ng/mL for spine and cardiac surgery, respectively. Median time to C_max of liposomal bupivacaine occurred later with cardiac surgery versus spine surgery (22.7 vs 7.4 h). In age group 1, the incidence of adverse events (AEs) was comparable between liposomal bupivacaine (61% [19/31]) and bupivacaine HCl (73% [22/30]). In age group 2, 100% (5/5) and 31% (9/29) of patients undergoing spine and cardiac surgery experienced AEs, respectively. AEs were generally mild or moderate, with no discontinuations due to AEs or deaths.ConclusionsPlasma bupivacaine levels following local infiltration with liposomal bupivacaine remained below the toxic threshold in adults (~2000–4000 ng/mL) across age groups and procedures. AEs were mild to moderate, supporting the safety of liposomal bupivacaine in pediatric patients undergoing spine or cardiac surgery.Clinical trial number and registry URL: ClinicalTrials.gov identifier: NCT03682302     

Outcomes of individualized goal-directed therapy based on cerebral oxygen balance in high-risk patients undergoing cardiac surgery: A randomized controlled trial

Study objectiveTo investigate whether optimizing individualized goal-directed therapy (GDT) based on cerebral oxygen balance in high-risk surgical patients would reduce postoperative morbidity.DesignThis was a prospective, randomized, controlled study.SettingThe study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018.Patients146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled.InterventionPatients were randomized to an individualized GDT group or usual care group. Individualized GDT was targeted to achieve the following goals: A less than 20% decline in the regional cerebral oxygen saturation (rScO₂) level from baseline; a less than 20% decline in the mean arterial pressure (MAP) from baseline, as well as a bispectral index (BIS) of 45–60 before and after CPB and 40–45 during CPB.MeasurementsThe primary outcome was a composite endpoint of 30-day mortality and major postoperative complications.Main results128 completed the trial and were included in the modified intention-to-treat analysis. Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50–1.08; P = 0.15). Secondary analysis showed that 75 (59%) of 128 patients achieved individual targets (irrespective of intervention) and sustained less morbidity (relative risk 3.41, 95% CI 2.19–5.31; P < 0.001).ConclusionsIn high-risk patients undergoing cardiac surgery, individualized GDT therapy did not yield better outcomes, however, the achievement of preoperative individual targets may be associated with less morbidity.Trial registrationClinicaltrials.gov identifier: NCT03103633. Registered on 1 April 2017.     

Preoperative oximetry-derived hypoxemia predicts postoperative cardiovascular events in surgical patients with unrecognized obstructive sleep apnea

Study objectiveObstructive sleep apnea (OSA) is known to be associated with postoperative cardiovascular events in patients undergoing major non-cardiac surgery. The objective of the study is to determine whether preoperative oximetry-derived hypoxemia predicts postoperative cardiovascular events in surgical patients with unrecognized obstructive sleep apnea.Design and settingThe study was a planned post hoc analyses of a multicenter prospective cohort study.PatientsThe inclusion criteria were patients ≥45 years old undergoing major non-cardiac surgery with cardiovascular risk factors.Interventions and measurementsAll patients underwent pre-operative pulse oximetry (PULSOX-300i, Konica-Minolta Sensing, Inc). The severity of OSA was classified based on oxygen desaturation index (ODI) (mild: ≥5 to <15, moderate: ≥15 to <30, and severe OSA: ≥30 events/h). The 30 days cardiovascular events were a composite of myocardial injury, cardiac death, congestive heart failure, thromboembolism, atrial fibrillation, and stroke.Main resultsFor 1218 patients with mild, moderate, or severe OSA (mean age: 67.2 ± 9.3 years; body mass index: 27.0 ± 5.3 kg/m²), the rate of postoperative cardiovascular events was 16.4%, 25.2%, and 29.8% respectively. The multivariable analysis showed that preoperative oxygen desaturation index (ODI) ≥30 events per hour {adjusted hazard ratio (aHR) 1.63 [95% confidence interval (CI): 1.05–2.53]}, and cumulative time spent during sleep with oxygen saturation below 80% (CT80) ≥10 min {aHR 1.79 [95% CI: 1.28–2.50]} were independent predictors of 30-day postoperative cardiovascular events.ConclusionsPreoperative ODI ≥30 events per hour and CT80 ≥ 10 min are associated with increased risk of postoperative cardiovascular events. Preoperative screening using oximetry helps in risk stratification for unrecognized sleep apnea.Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01494181     

Critical care management of adult traumatic brain injury

Severe traumatic brain injury (TBI) is associated with significant morbidity and mortality. The critical care management of TBI requires a coordinated and comprehensive approach to treatment, including strategies to prevent secondary brain injury and maintenance of adequate cerebral perfusion and oxygenation. Management protocols have evolved with international consensus, providing guidelines that assist clinicians in delivering optimal care. Those from the Brain Trauma Foundation are continuously updated to incorporate new trial data (https://braintrauma.org/coma/guidelines).     

Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial

IntroductionThis report evaluates whether health related quality of life (HRQoL) and patient-reported arm morbidity one year after axillary surgery are affected by the omission of axillary lymph node dissection (ALND).MethodsThe ongoing international non-inferiority SENOMAC trial randomizes clinically node-negative breast cancer patients (T1-T3) with 1–2 sentinel lymph node (SLN) macrometastases to completion ALND or no further axillary surgery. For this analysis, the first 1181 patients enrolled in Sweden and Denmark between March 2015, and June 2019, were eligible. Data extraction from the trial database was on November 2020. This report covers the secondary outcomes of the SENOMAC trial: HRQoL and patient-reported arm morbidity. The EORTC QLQ-C30, EORTC QLQ-BR23 and Lymph-ICF questionnaires were completed in the early postoperative phase and at one-year follow-up. Adjusted one-year mean scores and mean differences between the groups are presented corrected for multiple testing.ResultsOverall, 976 questionnaires (501 in the SLN biopsy only group and 475 in the completion ALND group) were analysed, corresponding to a response rate of 82.6%. No significant group differences in overall HRQoL were identified. Participants receiving SLN biopsy only, reported significantly lower symptom scores on the EORTC subscales of pain, arm symptoms and breast symptoms. The Lymph-ICF domain scores of physical function, mental function and mobility activities were significantly in favour of the SLN biopsy only group.ConclusionOne year after surgery, arm morbidity is significantly worse affected by ALND than by SLN biopsy only. The results underline the importance of ongoing attempts to safely de-escalate axillary surgery.Trial registrationThe trial was registered at clinicaltrials.gov prior to initiation (https://clinicaltrials.gov/ct2/show/NCT 02240472).     

Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial

ObjectiveCompare transversus abdominis plane (TAP) blocks with liposomal bupivacaine were to epidural analgesia for pain at rest and opioid consumption in patients recovering from abdominal surgery.BackgroundERAS pathways suggest TAP blocks in preference to epidural analgesia for abdominal surgery. However, the relative efficacies of TAP blocks and epidural analgesia remains unknown.MethodsPatients having major abdominal surgery were enrolled at six sites and randomly assigned 1:1 to thoracic epidural analgesia or bilateral/4-quadrant TAP blocks with liposomal bupivacaine. Intravenous opioids were used as needed. Non-inferiority margins were a priori set at 1 point on an 11-point pain numeric rating scale for pain at rest and at a 25% increase in postoperative opioid consumption.ResultsEnrollment was stopped per protocol at 3rd interim analysis after crossing an a priori futility boundary. 498 patients were analyzed (255 had TAP blocks and 243 had epidurals). Pain scores at rest in patients assigned to TAP blocks were significantly non-inferior to those given epidurals, with an estimated difference of 0.09 points (CI: −0.12, 0.30; noninferiority P < 0.001). Opioid consumption during the initial 3 postoperative days in TAP patients was not non-inferior to epidurals, with an estimated ratio of geometric means of 1.37 (CI: 1.05, 1.79; non-inferiority P = 0.754). However, the absolute difference was only 21 mg morphine equivalents over the 3 days. Patients with epidurals were more likely to experience mean arterial pressures <65 mmHg than those given TAP blocks: 48% versus 31%, P = 0.006.ConclusionPain scores at rest during the initial three days after major abdominal surgery were similar. Patients assigned to TAP blocks required more opioid then epidural patients but had less hypotension. Clinicians should reconsider epidural analgesia in patients at risk from hypotension.Trial Registration: ClinicalTrials.gov Identifier: NCT02996227.     

Remote transmission monitoring for postoperative perineural analgesia after major orthopedic surgery: A multicenter,randomized, parallel-group,controlled trial

Study objectiveAfter surgery, patients reported the delay in receiving help as the primary factor for poorly controlled pain. This study aimed to compare the effectiveness of patient management through two communication modalities: remote transmission (RT) versus bedside control (BC). We hypothesized that using remote technology for pump programming may provide the best postoperative infusion regimen for the patient's self-assessment of pain and adverse events.DesignA multicenter, randomized, parallel-group, controlled trial.SettingAnesthesiology department and orthopedic surgery ward at three university hospitals.PatientsEighty patients undergoing orthopedic surgery with postoperative perineural patient-controlled analgesia were included.InterventionsTwo groups (n = 40 for each group) were formed by randomization. In the postoperative period, perineural analgesia was followed up via an RT system or BC for 72 h.MeasurementsA nurse assessed daily pain, sensory and motor blocks and adverse events. Patients completed a questionnaire three times a day and alerted for any problem according to the group (RT system or nurses' follow-up). On the third postoperative day, the nurse removed the catheter, completed the final assessment, and collected the historical data from the pump. A physician's shorter response time to change the patient control analgesia (PCA) program was the primary endpoint.ResultsOf the 80 patients, 71 were analyzed (34 were randomized to the RT group and 37 to the BC group). Fifty-eight pump setting changes were noted. Analysis of repeated evaluations shows that mean time (SD) to change the PCA pump settings was significantly lower in the RT group (20 min (22.3 min)) than in the BC group (55.9 min (71.1 min)); mean difference [95% CI], −35.9 min [−74.3 to 2.4]); β estimation [95% CI], −34 [−63 to −6], p = 0.011). Pain relief, sensory and motor blocks did not differ between the groups: β estimation [95% CI], 0.1 [−0.4 to 0.6], p = 0.753; 0.5 [−0.4 to 1.4], p = 0.255; 0.9 [−0.04 to 1.8], p = 0.687, respectively. β = −34 [−63 to −6], p = 0.011). The consumption of ropivacaine, nurse workload and the cost of the analgesia regimen decreased in the RT group. No differences were noted in satisfaction scores or complication rates.ConclusionsThe response time for the physician to change the PCA program when necessary was shorter for patients using RT and alerts to the physician were more frequent compared with spot checks by nurses. RT helps to decrease nurses' workload, ropivacaine consumption, and costs but did not affect postoperative pain relief, complication rate, or patient-reported satisfaction score.IRB contact informationComité de Protection des Personnes, Sud Méditerranée III, Montpellier-Nîmes, France, registration number EudraCT A01698-35.Clinical trial numberClinicalTrials.gov ID:NCT02018068ProtocolThe full trial protocol can be accessed at Department of Anesthesiology and Critical Care Medicine, Medical Research and Statistics Unit, Lapeyronie University Hospital, Avenue Doten G Giraud, Montpellier, France. s-bringuierbranchereau@chu-montpellier.fr     

Exploratory study of VVZ-149, a novel analgesic molecule,in the affective component of acute postoperative pain after laparoscopic colorectal surgery

Study objectiveVVZ-149 is a small molecule that inhibits the glycine transporter type 2 and the serotonin receptor 5-hydroxytryptamine 2A. In the present study, we investigated the efficacy and safety of VVZ-149 as a single-use injectable analgesic for treating moderate to severe postoperative pain after colorectal surgery.DesignRandomized, parallel group, double-blind Phase 2 clinical trial (NCT02489526).Setting3 academic institutions in the United States.Patients60 patients undergoing laparoscopic colorectal surgery.InterventionsA continuous 8-h intravenous infusion of VVZ-149 Injections (n = 40) or placebo (n = 20) administered after emergence from anesthesia.MeasurementsThe outcome measures included pain intensity (PI), opioid consumption via patient-controlled analgesia (PCA), and rescue dosing provided “as needed”. Early rescue dosing with opioids postoperatively was associated with preoperative negative affect (anxiety, depression, and pain catastrophizing), enabling it to be used as an indirect measure of the affective component of pain. Efficacy outcomes were compared between treatment groups based on preoperative negative affect and early rescue dosing of opioids.Main resultsPostoperative PI was non-significantly lower in patients receiving VVZ-149 compared to those receiving placebo. The VVZ-149 group had a 34.2% reduction in opioid consumption for 24 h post-dose, along with fewer PCA demands. Somnolence and headache was higher in the intervention group. For patients characterized by high levels of preoperative negative affect, the VVZ-149 group experienced a significant pain reduction and 40% less opioid use compared to the placebo group.ConclusionsVVZ-149 resulted in a non-significant reduction of postoperative pain during the first 8 h after surgery. Post hoc analysis indicates that VVZ-149 may benefit patients with negative affect who otherwise have higher postoperative opioid use.Registration numberwww.clinicaltrials.gov, ID: NCT02489526.     

Immunologic response and seroconversion following third-dose COVID-19 vaccination in solid organ transplant recipients: A meta-analysis

IntroductionThe immunogenicity and efficacy of COVID-19 vaccination varied by demographic, including solid organ transplant recipients on immunosuppressive therapy.AimThis purpose of this study is to assess seropositivity and seroconversion in solid-organ transplant recipients before and after third-dose COVID-19 vaccination.MethodsThis study is a systematic review and meta-analysis performed using PRISMA guidelines. To analyze clinical and cohort studies reporting immunologic response and seroconversion third-dose vaccination, a systematic search was performed using electronic databases (PubMed, Scopus, Cochrane, Directory of Open Access Journal (DOAJ), and Clinicaltrials.gov).ResultThere were 18 full-text papers that could be analyzed qualitatively and quantitatively. After the third vaccination, the pooled rate seropositivity was 67.00% (95% CI 59.511; 74.047, I2 = 93.82%), and the pooled rate seroconversion was 52.51% (95% CI 44.03; 60.91, I2 = 92.15%). The pooled rate of seroconversion after the mRNA-based booster was 52.380% (95% CI 40.988; 63.649, I2 = 94.35%), and after the viral-vector-based booster was 42.478% (95% CI 35.222; 49.900, I2 = 0.00%).ConclusionBased on the analysis of immunologic responses and seroconversion findings, the third-dose vaccination of solid organ transplant recipients is an effective method in establishing better immunity against COVID-19.     

Transcutaneous electrical acupoint stimulation before surgery reduces chronic pain after mastectomy: A randomized clinical trial

Study objectiveDespite multiple interventions, the incidence of chronic pain after mastectomy could be as high as 50% after surgery. This study aimed to determine the efficacy of transcutaneous electrical acupoint stimulation (TEAS) before anesthesia induction in reducing chronic pain and to compare the effect of combined acupoint TEAS with that of single acupoint TEAS.DesignA multicenter randomized clinical trial.SettingThe study was conducted at six medical centers in China from May 2016 to April 2018. Final follow-up was on October 26, 2018.ParticipantsEligible patients were women scheduled for radical mastectomy under general anesthesia.InterventionsPatients were randomly and equally grouped into sham control (n = 188), single acupoint (PC6, n = 198), or combined acupoints (PC6 and CV17, n = 190) TEAS groups using a centralized computer-generated randomization system. TEAS was applied for 30 min before anesthesia induction. The sham-operated control group received electrode attachment but without stimulation. Anesthesiologists, surgeons, and outcome assessors were blinded to the interventions.MeasuresThe primary endpoint was the incidence of chronic pain 6 months after surgery. Incidences were compared among the groups using the unadjusted χ² test.ResultsOf the 576 randomized patients, 568 completed the trial. In the intention-to-treat analysis, post-mastectomy pain at 6 months was reported in 42 of 190 patients (22.1%) in the combined acupoints group, 65 of 188 patients (34.6%) in the sham-operated group (P = 0.007; relative risk [RR], 95% confidence interval [CI]: 0.68, 0.52–0.89), and 72 of 198 patients (36.4%) in the single acupoint group (P = 0.002; RR, 95% CI: 0.72, 0.55–0.93). Remifentanil consumption during surgery and postoperative nausea and vomiting at 24 h after surgery were lower in the combined acupoint group than that in the sham-operated group.ConclusionTEAS at combined acupoints before surgery was associated with reduced chronic pain 6 months after surgery.Trial registration: Clinicaltrials.gov identifier: NCT02741726. Registered on April 13, 2016.     

Perioperative supplemental oxygen and NT-proBNP concentrations after major abdominal surgery – A prospective randomized clinical trial

Study objectiveSupplemental oxygen is a simple method to improve arterial oxygen saturation and might therefore improve myocardial oxygenation. Thus, we tested whether intraoperative supplemental oxygen reduces the risk of impaired cardiac function diagnosed with NT-proBNP and myocardial injury after noncardiac surgery (MINS) diagnosed with high-sensitivity Troponin T.DesignParallel-arm double-blinded single-centre superiority randomized trial.SettingOperating room and postoperative recovery area.Patients260 patients over the age of 45 years at-risk for cardiovascular complications undergoing major abdominal surgery.InterventionAdministration of 80% versus 30% oxygen throughout surgery and for the first two postoperative hours.MeasurementsThe primary outcome was the postoperative maximum NT-proBNP concentration in both groups, which was assessed within 2 h after surgery, and on the first and third postoperative day. The secondary outcome was the incidence of MINS in both groups.Main results128 patients received 80% oxygen and 130 received 30% oxygen throughout surgery and for the first two postoperative hours. There was no significant difference in the median postoperative maximum NT-proBNP concentration between the 80% and the 30% oxygen group (989 pg.mL⁻¹ [IQR 499; 2005] and 810 pg.mL⁻¹ [IQR 409; 2386], effect estimate: 159 pg.mL⁻¹, 95%CI -123, 431, p = 0.704). There was no difference in the incidence of MINS between both groups. (p = 0.703).ConclusionsThere was no beneficial effect of perioperative supplemental oxygen administration on postoperative NT-proBNP concentration and MINS. It seems likely that supplemental oxygen has no effect on the release of NT-proBNP in patients at-risk for cardiovascular complications undergoing major abdominal surgery.Trial registrationClinicalTrials.gov: NCT 03366857.https://clinicaltrials.gov/ct2/results?cond=NCT+03366857&term=&cntry=&state=&city=&dist=     

Ketamine vs. haloperidol for prevention of cognitive dysfunction and postoperative delirium: A phase IV multicentre randomised placebo-controlled double-blind clinical trial

Study objectiveDelirium is frequently observed in the postoperative and intensive care unit (ICU) population. Due to the multifactorial origin of delirium and according to international guidelines (e.g., American Geriatrics Society; Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption (PADIS) guideline), there are several but no incontestable options for prevention and symptomatic treatment.The purpose of the Baden PRIDe (Prevention and Reduction of Incidence of postoperative Delirium) trial was to determine whether postoperative cognitive dysfunction and delirium could be prevented by the combination of possible preventive agents such as haloperidol and ketamine. In addition, pre- and postoperative levels of the biomarkers cortisol, neuron specific enolase (NSE) and S100β were measured to investigate their dynamics in delirious and non-delirious patients after surgery.DesignThe Baden PRIDe Trial was an investigator-initiated, phase IV, two-centre, randomised, placebo-controlled, double-blind clinical trial.SettingPerioperative care.Patients182 adult patients that underwent elective or emergency surgery under general or combined (i.e., general and regional) anaesthesia.InterventionsPre-anaesthetic, pharmacologic prevention of postoperative brain dysfunction with haloperidol, ketamine, and the combination of both vs. placebo.MeasurementsAssessment of cognitive performance pre- and postoperatively with the MMSE, the DOS, the Nursing Delirium Screening Scale (Nu-DESC) or the Intensive Care Delirium Screening Checklist (ICDSC) during ICU stay.Main resultsNone of the three study arms – haloperidol, ketamine, or both drugs combined - was significantly superior to placebo for prevention of postoperative brain dysfunction and delirium (P = 0.39). Measured levels of postoperative cortisol were significantly higher in delirious patients. S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.ConclusionsThe study results offer no possibility for a novel recommendation for prevention of postoperative cognitive decline including delirium. Perioperative S-100β trajectories in patients with cognitive deterioration suggest affection of glial cells in particular.Trial registrationClinicalTrials.gov NCT02433041; registered on April 7, 2015.     

Postoperative opioid administration characteristics associated with opioid-induced respiratory depression: Results from the PRODIGY trial

Study objectiveOpioid administration for pain in general care floor patients remains common, and can lead to adverse outcomes, including respiratory compromise. The PRODIGY trial found that among ward patients receiving parenteral opioids, 46% experienced ≥1 respiratory depression episode. The objective of this analysis was to evaluate the geographic differences of opioid administration and examine the association between opioid administration characteristics and the occurrence of respiratory depression.DesignProspective observational trial.Setting16 general care medical and surgical wards in Asia, Europe, and the United States.Patients1335 patients receiving parenteral opioids.InterventionsBlinded, alarm-silenced continuous capnography and pulse oximetry monitoring.MeasurementsOpioid-induced respiratory depression, defined as respiratory rate ≤ 5 bpm, SpO₂ ≤ 85%, or ETCO₂ ≤ 15 or ≥ 60 mmHg for ≥3 min; apnea episode lasting >30 s; or any respiratory opioid-related adverse event.ResultsAcross all patients, 58% received only long-acting opioids, 16% received only short-acting (<3 h) opioids, and 21% received a combination of short- and long-acting (≥3 h) opioids. The type and median total morphine milligram equivalent (MME) of opioid administered varied significantly by region, with 31.5 (12.5–76.7) MME, 31.0 (6.2–99.0) MME, and 7.2 (1.7–18.7) MME in the United States, Europe, and Asia, respectively (p < 0.001). Considering only postoperative opioids, 54% (N = 119/220) and 45% (N = 347/779) of patients receiving only short-acting opioids or only long-acting opioids experienced ≥1 episode of opioid-induced respiratory depression, respectively. Multivariable analysis identified post-procedure tramadol (OR 0.62, 95% CI 0.424–0.905, p = 0.0133) and post-procedure epidural opioids (OR 0.485, 95% CI 0.322–0.731, p = 0.0005) being associated with a significant reduction in opioid-induced respiratory depression.ConclusionsDespite varying opioid administration characteristics between Asia, Europe, and the United States, opioid-induced respiratory depression remains a common global problem on general care medical and surgical wards. While the use of post-procedure tramadol or post-procedure epidural opioids may reduce the incidence of respiratory depression, continuous monitoring is also necessary to ensure patient safety when receiving postoperative opioids.Registration numberwww.clinicaltrials.gov, ID: NCT02811302     

Nasal continuous positive pressure versus simple face mask oxygenation for adult obese and obstructive sleep apnea patients undergoing colonoscopy under propofol-based general anesthesia without tracheal intubation: A randomized controlled trial

Study objectiveTo determine if a nasal positive airway pressure (nasal CPAP) mask would decrease the number of hypoxemic events in obese and obstructive sleep apnea patients undergoing colonoscopy.DesignSingle-center prospective randomized controlled trial.SettingTertiary academic center.PatientsWe enrolled 109 patients with diagnosis of obesity and/or obstructive sleep apnea scheduled to undergo colonoscopy under propofol general anesthesia without planned tracheal intubation.InterventionPatients were randomly allocated (1:1 ratio) to receive supplementary oxygen at a flow of 10 L/min, either through a nasal CPAP or a simple facemask.MeasurementsThe primary endpoint was the difference in the mean percentage of time spent with oxygen saturation below 90% between the two groups. Secondary outcomes included the need for airway maneuvers/interventions, average SpO2 during the case, duration and severity of oxygen desaturation, incidence and duration of procedural interruptions, and satisfaction and tolerance scores.Main results54 were allocated to the simple face mask and 55 to the nasal CPAP mask arms, respectively. A total of 6 patients experienced a hypoxemic event. Among these patients, the difference in the percentage of time spent with oxygen saturation below 90% was not clinically relevant (p = 1.0). However, patients in the nasal CPAP group required less chin lift (20% vs. 42.6%; p = 0.01) and oral cannula insertion (12.7% vs.29.6%; p = 0.03). The percentage of patients with at least one airway maneuver was higher in the simple face mask arm (68.5% vs. 41.8%; p = 0.005). Patient tolerance to device score was lower in the nasal CPAP group (8.85 vs. 9.56; p = 0.003).ConclusionsA nasal CPAP did not prevent hypoxemia and should not be used routinely for colonoscopy in obese or OSA patients if a simple face mask is an alternative therapy. However, potential advantages of its use include fewer airway maneuvers or interventions, which may be desirable in certain clinical settings.Trial registrationClinicaltrials.gov, identifier: NCT05175573.     

Tracheal intubation using intubating laryngeal tube iLTS-D™ and LMA Fastrach™ in 99 adult patients: A prospective multicentric randomised non-inferiority study

Study objectiveThis study aimed to investigate the overall success of tracheal intubation using the intubating Laryngeal Tube Suction-Disposable (iLTS-D™, VBM, Sulz a. N., Germany) compared to the Laryngeal Mask Airway (LMA) Fastrach™ (Teleflex, Athlone, Ireland). We hypothesised that the iLTS-D™ would be non-inferior to the LMA Fastrach™ for tracheal intubation and ventilation.DesignMulticentric, non-inferiority, randomised controlled study.SettingOperating rooms from two tertiary and one secondary centre in Switzerland from January 2017 to July 2019. The investigators were trained anaesthetists with extensive experience with laryngeal masks but limited to laryngeal tubes. The study was discontinued after the planned interim analysis.PatientsNinety-nine adult patients were included after randomisation. The inclusion criteria were American Society of Anesthesiologists physical status 1 to 3 in patients scheduled for elective surgery requiring tracheal intubation. Patients with a history of difficult intubation were excluded.Intervention(s)After anaesthesia induction and once neuromuscular blockade was obtained, ventilation was initiated, and tracheal intubation was performed through the randomised device with the flexible endoscope tip placed proximally to the tip of the tracheal tube (visualised blind intubation).MeasurementsThe primary outcome was the intubation success rate after two attempts. The secondary outcomes were time to intubation, successful ventilation rate, time to achieve ventilation, and gastric access success rate.Main resultsThe overall intubation success rate was significantly higher in the Fastrach™ group than in the iLTS-D™ group (91.8% vs 70.0%, p = 0.006). No difference was found in the ventilation success rate (94% for iLTS-D™ and 100% for LMA Fastrach™ [p = 0.829]). The time to achieve ventilation and intubation were similar between the groups. No major airway complications were noted.ConclusionsAlthough both supraglottic devices provided the same effective ventilation rate, the LMA Fastrach™ was superior to the iLTS-D™ as a conduit for intubation in 99 adult patients without a known difficult intubation. These preliminary results need to be confirmed in studies that include a larger population.Trial registration: Clinicaltrials.gov, 21.09.2016, Identification Number NCT02922595.     

How to Develop and Validate Prediction Models for Orthopedic Outcomes

Prediction models are common in medicine for predicting outcomes such as mortality, complications, or response to treatment. Despite the growing interest in these models in arthroplasty (and orthopaedics in general), few have been adopted in clinical practice. If robustly built and validated, prediction models can be excellent tools to support surgical decision making. In this paper, we provide an overview of the statistical concepts surrounding prediction models and outline practical steps for prediction model development and validation in arthroplasty research. Please visit the following https://www.youtube.com/watch?v=9Yrit23Rkic for a video that explains the highlights of the paper in practical terms.