Tight computerized versus conventional glucose control in the ICU: a randomized controlled trial

Purpose

The blood glucose target range and optimal method to reach this range remain a matter of debate in the intensive care unit (ICU). A computer decision support system (CDSS) might improve the outcome of ICU patients through facilitation of a tighter blood glucose control.

Methods

We conducted a multi-center randomized trial in 34 French ICU. Adult patients expected to require treatment in the ICU for at least 3 days were randomly assigned without blinding to undergo tight computerized glucose control with the CDSS (TGC) or conventional glucose control (CGC), with blood glucose targets of 4.4–6.1 and <10.0 mmol/L, respectively. The primary outcome was all-cause death within 90 days after ICU admission.

Results

Of the 2,684 patients who underwent randomization to the TGC and CGC treatment groups, primary outcome was available for 1,335 and 1,311 patients, respectively. The baseline characteristics of these treatment groups were similar in terms of age (61 ± 16 years), SAPS II (51 ± 19), percentage of surgical admissions (40.0 %) and proportion of diabetic patients (20.3 %). A total of 431 (32.3 %) patients in the TGC group and 447 (34.1 %) in the CGC group had died by day 90 (odds ratio for death in the TGC 0.92; 95 % confidence interval 0.78–1.78; p = 0.32). Severe hypoglycemia (<2.2 mmol/L) occurred in 174 of 1,317 patients (13.2 %) in the TGC group and 79 of 1,284 patients (6.2 %) in the CGC group (p < 0.001).

Conclusions

Tight computerized glucose control with the CDSS did not significantly change 90-day mortality and was associated with more frequent severe hypoglycemia episodes in comparison with conventional glucose control.     

Gasless laparoscopically assisted myomectomy using a wound retraction system

Introduction: The purpose of this study was to elucidate the feasibility of gasless laparoscopically assisted myomectomy (LAM) using a wound retraction system. This method treats symptomatic uterine myomas by combining laparoscopy with a mini‐laparotomy to enucleate myoma nodules and to close the uterine myometrium. Methods: This study includes 275 patients who underwent gasless LAM. For patients with fewer than three myoma nodules, the location of the largest nodule was classified as anterior, fundal, or posterior. The operative outcomes, intraoperative and postoperative courses, and complications were examined. Results: All operations were performed satisfactorily, and no conversions to laparotomy were required. None of the patients developed serious complications. The mean blood loss and operating time were 190.3 mL and 152.2 minutes, respectively. The mean myoma size was 8.9 cm, and the mean number of myomas per patient was 2.8. The average postoperative hospital stay was 5.7 days. There were no significant differences in resected myoma size, blood loss, and surgical duration with respect to the location of the largest nodule. Conclusion: Gasless LAM with a wound retractor is feasible and allows surgeons to perform myomectomy safely and cost‐effectively, without requiring advanced laparoscopic surgical skills and while maintaining minimum invasiveness.     

腹腔镜下子宫大肌瘤剔除术方法改进

目的该研究通过对腹腔镜下大子宫肌瘤剔除术方法的改进,探讨其临床效果。方法选择肌瘤直径≥5 cm为研究对象,其中改进腹腔镜下子宫肌瘤剔除术组(改进组)50例与以往腹腔镜子宫肌瘤剔除术组(对照组)58例进行比较,观察术中出血,手术时间,手术并发症等。结果对改进后腹腔镜下肌瘤剔除术组(改进组)与常规腹腔镜下肌瘤剔除组(对照组)进行比较:其中,手术时间:改进组(101.90±30.84)min,对照组(136.90±49.87)min;P0.001,术中出血:改进组(145.40±92.19)ml,对照组(207.41±158.74)ml;P0.05,手术并发症:改进组术中无输血,对照组术中输血3例;改进组术后无肠粘连发生,对照组肠粘连2例。结论腹腔镜下较大子宫肌瘤剔除方法安全且可行,改进后手术时间短且出血少,减少了输血事件发生,降低了手术并发症。     

Comparison of Photodynamic Therapy versus conventional antifungal therapy for the treatment of denture stomatitis: a randomized clinical trial

Clin Microbiol Infect 2012; 18: E380-E388 ABSTRACT: In this randomized clinical trial, the clinical and mycological efficacy of Photodynamic Therapy (PDT) was compared with that of topical antifungal therapy for the treatment of denture stomatitis (DS) and the prevalence of Candida species was identified. Patients were randomly assigned to one of two groups (n?=?20 each); in the nystatin (NYT) group patients received topical treatment with nystatin (100?000?IU) four times daily for 15?days and in the PDT group the denture and palate of patients were sprayed with 500?mg/L of Photogem(?) , and after 30?min of incubation, were illuminated by light emitting-diode light at 455?nm (37.5 and 122?J/cm(2) , respectively) three times a week for 15?days. Mycological cultures taken from dentures and palates and standard photographs of the palates were taken at baseline (day 0), at the end of the treatment (day 15) and at the follow-up time intervals (days 30, 60 and 90). Colonies were quantified (CFU/mL) and identified by biochemical tests. Data were analysed by Fisher's exact test, analysis of variance and Tukey tests and κ test (α?=?0.05). Both treatments significantly reduced the CFU/mL at the end of the treatments and on day 30 of the follow-up period (p?<0.05). The NYT and PDT groups showed clinical success rates of 53% and 45%, respectively. Candida albicans was the most prevalent species identified. PDT was as effective as topical nystatin in the treatment of DS.     

A randomized controlled feasibility trial comparing safety and effectiveness of prehospital pacing versus conventional treatment: 'PrePACE'

OBJECTIVE: To evaluate the feasibility of a prehospital randomized controlled trial comparing transcutaneous pacing (TCP) with dopamine for unstable bradycardia. METHODS: Unstable bradycardic patients who failed to respond to a fluid bolus and up to 3mg atropine were enrolled. The intervention was dopamine or TCP with crossover to dopamine if TCP failed. The primary outcome was survival to discharge or 30 days. Randomization compliance, safety, follow-up rates, primary outcome, and sample size requirements were assessed. RESULTS: Of 383 patients with unstable bradycardia, 151 (39%) failed to respond to atropine or fluid and were eligible for enrollment and 82 (55%) were correctly enrolled. Fifty-five (36%) of eligible patients could not be enrolled for practical reasons; 3 had advance directives, 32 met inclusion criteria on arrival at hospital and in 20 cases, paramedics chose not to enroll based on the circumstances of the case. The remaining 13 were missed cases; 8 were missing randomization envelopes and in 5, the paramedic forgot. Randomization compliance was 95% (78/82). Forty-two (51%) patients were randomized to TCP and seven of these crossed over to dopamine. Two cases were randomized but did not receive the intervention; either due to lack of time or loss of IV access. Three adverse events occurred in each group. Survival to discharge or 30 days in hospital was 70% (28/40) and 69% (29/42) in the dopamine and TCP groups, respectively with 100% follow up. To detect a 10% relative difference in 30 days survival between treatment arms, a sample size of 690 per group would be required. CONCLUSIONS: It is feasible to conduct a prehospital randomized controlled trial of TCP for unstable bradycardia and a definitive trial would require a multi-centre study.     

Hydrotherapy versus conventional land-based exercise for the management of patients with osteoarthritis of the knee: a randomized clinical trial

BACKGROUND AND PURPOSE: This study was designed to evaluate the effectiveness of hydrotherapy in subjects with osteoarthritis (OA) of the knee compared with subjects with OA of the knee who performed land-based exercises. SUBJECTS AND METHODS: Sixty-four subjects with OA of the knee were randomly assigned to 1 of 2 groups that performed exercises for 18 weeks: a water-based exercise group and a land-based exercise group. The outcome measures included a visual analog scale (VAS) for pain in the previous week, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), pain during gait assessed by a VAS at rest and immediately following a 50-foot (15.24-m) walk test (50FWT), walking time measured at fast and comfortable paces during the 50FWT, and the Lequesne Index. Measurements were recorded by a blinded investigator at baseline and at 9 and 18 weeks after initiating the intervention. RESULTS: The 2 groups were homogenous regarding all parameters at baseline. Reductions in pain and improvements in WOMAC and Lequesne index scores were similar between groups. Pain before and after the 50FWT decreased significantly over time in both groups. However, the water-based exercise group experienced a significantly greater decrease in pain than the land-based exercise group before and after the 50FWT at the week-18 follow-up. DISCUSSION AND CONCLUSION: Both water-based and land-based exercises reduced knee pain and increased knee function in participants with OA of the knee. Hydrotherapy was superior to land-based exercise in relieving pain before and after walking during the last follow-up. Water-based exercises are a suitable and effective alternative for the management of OA of the knee.     

Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treatment of malaria: a randomized trial

Objectives:     

A randomized trial of unsedated transnasal small-caliber esophagogastroduodenoscopy (EGD) versus peroral small-caliber EGD versus conventional EGD

BACKGROUND AND STUDY AIMS: Unsedated esophagogastroduodenoscopy (EGD) has advantages over sedated EGD - e. g., prevention of side effects related to sedation, less patient monitoring, and less expense. This study compared the feasibility and tolerance of transnasal small-caliber (TSC-EGD) and peroral small-caliber EGD (PSC-EGD) with conventional EGD (C-EGD). PATIENTS AND METHODS: A total of 150 patients referred for diagnostic EGD were randomly allocated to undergo either TSC-EGD, PSC-EGD, or C-EGD under local anesthesia if they agreed to receive sedation only on demand or in case of intolerance. Patients, endoscopists, and nurses completed questionnaires on the tolerability and quality of the examinations using a visual analogue scale (VAS), ranging from 1 (best/nonexistent) to 10 (worst/unbearable) after EGD. Small-caliber EGD and C-EGD were performed with 5.9-mm and 9.8-mm video endoscopes (Olympus), respectively. RESULTS: The patients' age, sex, experience with EGD, and anxiety before EGD did not differ significantly between the three groups, each consisting of 50 patients. TSC-EGD failed in four of the 50 patients (8 %) because of a narrow nasal tract; they underwent PSC-EGD. Complete examinations, including the second part of the duodenum and biopsy sampling, were possible in all patients. Patients examined with an ultrathin instrument required sedation significantly less often (TSC-EGD 6 %, PSC-EGD 18 %, C-EGD 44 %; P < 0.01) and consequently spent less time in the recovery room. TSC-EGD was initially more painful on insertion, but caused less gagging (P<0.01) than peroral EGD during the whole procedure. TSC-EGD caused mild epistaxis in one case. CONCLUSIONS: TSC-EGD was carried out safely and completely in 92 % of the patients. TSC-EGD and PSC-EGD were better tolerated and required sedation less often than conventional EGD. Transnasal diagnostic EGD appears to be a promising alternative to peroral EGD, as it is associated with less gagging and a high level of patient satisfaction.     

Automated versus manual blood pressure measurement: a randomized crossover trial

This study evaluated the accuracy and reliability of the Dinamap 8100 automated blood pressure machine against three internationally recognized criteria. Systolic and diastolic blood pressures were taken concurrently by two nurses using the automated machine and a manual sphygmomanometer. Results demonstrated agreement between automated and manual readings on one set of criteria for both systolic and diastolic pressures, and support for systolic readings only on one other criterion. Comparison of mean differences between automated and manual measures showed the automated machine consistently under-read both systolic and diastolic blood pressures. The conclusion from this study was that the Dinamap 8100 machine can be used with some degree of confidence to assess systolic blood pressures in a general population of adult hospital inpatients, but with caution when taking diastolic readings.     

Precut papillotomy versus persistence in difficult biliary cannulation: a prospective randomized trial

BACKGROUND AND STUDY AIMS: Failed biliary cannulation occurs in up to 10% of patients undergoing ERCP. There is some controversy as to the safety and efficacy of using precut techniques to achieve biliary cannulation in difficult cases. To date, no randomized trial has compared the success and complication rates of precut with the rates for persistence when biliary cannulation is difficult. The aim of this study was to compare the success rates and complication rates of precut with the success rates and complication rates of persistence in cases of difficult biliary cannulation. PATIENTS AND METHODS: Patients without prior sphincterotomy who required biliary cannulation were screened. A "difficult biliary cannulation" was arbitrarily defined as failed cannulation after 12 minutes. These patients were then randomized to continue treatment by needle-knife cut over the roof of the papilla or by persistence with a non-wire-guided, single-lumen papillotome. "Primary" success was defined as deep cannulation within 15 minutes of randomization. Primary and final success rates and complication rates within 30 days after ERCP were compared. RESULTS: Over a 38-month period a total of 642 patients were screened. Patients in whom biliary cannulation was successful within a time period of 12 minutes or less formed the reference group (n = 580). The remainder of the patients were randomly assigned to the "precut" arm (n = 32) or to the "persistence" arm (n = 30). Primary success rates and complication rates were similar in the precut and persistence arms (75% and 4% respectively for the precut arm vs. 73% and 9% for the persistence arm). The final successful cannulation rate in the entire group of 642 patients was 99.5%. CONCLUSIONS: In experienced hands, precut papillotomy and persistence in cannulation are equally effective in cases of difficult cannulation, with a similar complication rate.     

Nurses versus physician-led interhospital critical care transport: a randomized non-inferiority trial

Purpose

Regionalization and concentration of critical care increases the need for interhospital transport. However, optimal staffing of ground critical care transport has not been evaluated.

Methods

In this prospective, randomized, open-label, blinded-endpoint non-inferiority trial, critically ill patients on mechanical ventilation transported by interhospital ground critical care transport were randomized between transport staffed by a dedicated team comprising a critical care nurse and paramedic (nurses group) or a dedicated team including a critical care physician (nurses + physician group). The primary outcome was the number of patients with critical events, both clinical and technical, during transport. Clinical events included decrease in blood pressure, oxygen saturation, or temperature, blood loss, new cardiac arrhythmias, or death. Non-inferiority was assumed if the upper limit of the two-sided 90 % confidence interval (CI) for the between-group difference lies below the non-inferiority margin of 3 %.

Results

Of 618 eligible transported critically ill patients, 298 could be analyzed after randomization and allocation to the nurses group (n = 147) or nurses + physician group (n = 151). The percentages of patients with critical events were 16.3 % (24 incidents in 147 transports) in the nurses group and 15.2 % (23 incidents in 151 transports) in the nurses + physician group (difference 1.1 %, two-sided 90 % CI [?5.9 to 8.1]). Critical events occurred in both groups at a higher than the expected (0–1 %) rate. In the nurses group consultations for physician assistance were requested in 8.2 % (12 in 147 transports), all of which were performed prior to transport.

Conclusions

The number of patients with critical events did not markedly differ between critical care transports staffed by a critical care nurse and paramedic compared to a team including a critical care physician. However, as a result of an unexpected higher rate of critical events in both groups recorded by an electronic health record, non-inferiority of nurse-led interhospital critical transport could not be established (http://www.controlled-trials.com/ISRCTN39701540).

     

Efficacy of supervised Tai Chi exercises versus conventional physical therapy exercises in fall prevention for frail older adults: a randomized controlled trial

Purpose: To compare the effectiveness of supervised Tai Chi exercises versus the conventional physical therapy exercises in a personalized rehabilitation program in terms of the incidence and severity of falls in a frail older population. Method: The participants were frail older adults living in the community, admitted to the day hospital program in Sherbrooke, Quebec, Canada (n = 152). They were randomized to receive a 15-week intervention, either by supervised Tai Chi exercises (n = 76) or conventional physical therapy (n = 76). Fall incidence and severity were assessed using both the calendar technique and phone interviews once a month during 12 months following the end of the intervention. Other variables were collected at baseline to compare the two groups: age, comorbidity, balance, sensory interaction on balance, and self-rated health. Results: Both interventions demonstrated a protective effect on falls but Tai Chi showed a greater one (RR = 0.74; 95% CI = 0.56–0.98) as compared to conventional physical therapy exercises. Conclusions: Supervised Tai Chi exercises as part of a rehabilitation program seem to be a more effective alternative to the conventional physical therapy exercises for this specific population.

Implications for Rehabilitation

• Seniors who have fallen have a 50% chance of falling again during the following year, leading them to reduce their outings and thus decrease their social activities.

• Frail older people could benefit more from an individualized intervention than the regular group program generally used in a Tai Chi intervention.

• Tai Chi exercises seems to be a good alternative to regular physiotherapy exercises as a part of a multidisciplinary intervention in preventing a subsequent fall over a 12-month period.

     

Acupuncture-like versus conventional transcutaneous electrical nerve stimulation in the management of active myofascial trigger points: A randomized controlled trial

PurposeMyofascial pain syndrome (MPS) is one of the most common causes of chronic musculoskeletal pain. The transcutaneous electrical nerve stimulation (TENS) is a non-expensive, safe, feasible modality, used recently for the treatment of MPS with promising but limited results. The purpose of this study was to determine the efficacy of acupuncture-like TENS (AL-TENS) vs conventional TENS (C-TENS) in the treatment of active myofascial trigger points.MethodsThis randomized controlled trial study was carried out with 60 consecutive patients with active trapezius trigger points referred to Physical Medicine and Rehabilitation Clinic. Participants randomly assigned to receive AL-TENS, C-TENS or sham TENS (S-TENS). The Visual Analogue Scale (VAS), Pressure Pain Thresholds (PPTs), and neck range of motion (ROM) were measured at baseline, after the first treatment sessions, after the final treatment session, and 3 months after the end of the last treatment session. Patients function was evaluated by Disabilities of the Arm, Shoulder, and Hand (DASH) at baseline, after the final treatment sessions, and 3 months after the end of intervention.ResultsThe interaction effect of time and group was significantly different when evaluating VAS (df = 4.65, F = 2.50, p = 0.038) and DASH (df = 2.63, F = 7.25, p < 0.001) in favor of active groups, as well as neck total lateral bending in favor of AL-TENS group compared other two groups (df = 4.16, F = 5.23, p = 0.001). Both VAS and DASH improved significantly at all follow-ups in AL-TENS and C-TENS groups. Of note, significant immediate improvement in all outcomes was observed only with AL-TENS.ConclusionsAccording to the present study, both AL-TENS and C-TENS were superior to placebo in pain reduction and functional improvement. Although both TENS techniques have similar efficiency on pain reduction, functional and pain perception improvement, the AL-TENS was the superior approach when evaluating neck lateral bending ROM.