High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study)

Purpose

Nasal continuous positive airway pressure (nCPAP) is currently the gold standard for respiratory support for moderate to severe acute viral bronchiolitis (AVB). Although oxygen delivery via high flow nasal cannula (HFNC) is increasingly used, evidence of its efficacy and safety is lacking in infants.

Methods

A randomized controlled trial was performed in five pediatric intensive care units (PICUs) to compare 7 cmH₂O nCPAP with 2 L/kg/min oxygen therapy administered with HFNC in infants up to 6 months old with moderate to severe AVB. The primary endpoint was the percentage of failure within 24 h of randomization using prespecified criteria. To satisfy noninferiority, the failure rate of HFNC had to lie within 15% of the failure rate of nCPAP. Secondary outcomes included success rate after crossover, intubation rate, length of stay, and serious adverse events.

Results

From November 2014 to March 2015, 142 infants were included and equally distributed into groups. The risk difference of ?19% (95% CI ?35 to ?3%) did not allow the conclusion of HFNC noninferiority (p = 0.707). Superiority analysis suggested a relative risk of success 1.63 (95% CI 1.02–2.63) higher with nCPAP. The success rate with the alternative respiratory support, intubation rate, durations of noninvasive and invasive ventilation, skin lesions, and length of PICU stay were comparable between groups. No patient had air leak syndrome or died.

Conclusion

In young infants with moderate to severe AVB, initial management with HFNC did not have a failure rate similar to that of nCPAP. This clinical trial was recorded in the National Library of Medicine registry (NCT 02457013).

     

Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow rates

Purpose

Limited data exist on the correlation between higher flow rates of high-flow nasal cannula (HFNC) and its physiologic effects in patients with acute hypoxemic respiratory failure (AHRF). We assessed the effects of HFNC delivered at increasing flow rate on inspiratory effort, work of breathing, minute ventilation, lung volumes, dynamic compliance and oxygenation in AHRF patients.

Methods

A prospective randomized cross-over study was performed in non-intubated patients with patients AHRF and a PaO₂/FiO₂ (arterial partial pressure of oxygen/fraction of inspired oxygen) ratio of ≤300 mmHg. A standard non-occlusive facial mask and HFNC at different flow rates (30, 45 and 60 l/min) were randomly applied, while maintaining constant FiO₂ (20 min/step). At the end of each phase, we measured arterial blood gases, inspiratory effort, based on swings in esophageal pressure (ΔPes) and on the esophageal pressure–time product (PTP_Pes), and lung volume, by electrical impedance tomography.

Results

Seventeen patients with AHRF were enrolled in the study. At increasing flow rate, HFNC reduced ΔPes (p < 0.001) and PTP_Pes (p < 0.001), while end-expiratory lung volume (ΔEELV), tidal volume to ΔPes ratio (V _T/ΔPes, which corresponds to dynamic lung compliance) and oxygenation improved (p < 0.01 for all factors). Higher HFNC flow rate also progressively reduced minute ventilation (p < 0.05) without any change in arterial CO₂ tension (p = 0.909). The decrease in ΔPes, PTP_Pes and minute ventilation at increasing flow rates was better described by exponential fitting, while ΔEELV, V _T/ΔPes and oxygenation improved linearly.

Conclusions

In this cohort of patients with AHRF, an increasing HFNC flow rate progressively decreased inspiratory effort and improved lung aeration, dynamic compliance and oxygenation. Most of the effect on inspiratory workload and CO₂ clearance was already obtained at the lowest flow rate.

     

Health-related outcomes of critically ill patients with and without sepsis

Purpose

To determine differences in health-related quality of life (HRQoL), survival and healthcare resource use of critically ill adults with and without sepsis.

Methods

We conducted a primary propensity score matched analysis of patients with and without sepsis enrolled in a large multicentre clinical trial. Outcomes included HRQoL at 6 months, survival to 2 years, length of ICU and hospital admission and cost of ICU and hospital treatment to 2 years.

Results

We obtained linked data for 3442 (97.3%) of 3537 eligible patients and matched 806/905 (89.0%) patients with sepsis with 806/2537 (31.7%) without. After matching, there were no significant differences in the proportion of survivors with and without sepsis reporting problems with mobility (37.8% vs. 38.7%, p?=?0.86), self-care (24.7% vs. 26.0%, p?=?0.44), usual activities (44.5% vs. 46.8%, p?=?0.28), pain/discomfort (42.4% vs. 41.6%, p?=?0.54) and anxiety/depression (36.9% vs. 37.7%, p?=?0.68). There was no significant difference in survival at 2 years: 482/792 (60.9%) vs. 485/799 (60.7%) (HR 1.01, 95% CI 0.86–1.18, p?=?0.94). The initial ICU and hospital admission were longer for patients with sepsis: 10.1?±?11.9 vs. 8.0?±?9.8 days (p?<?0.0001) and 22.8?±?21.2 vs. 19.1?±?19.0 days, (p?=?0.0003) respectively. The cost of ICU admissions was higher for patients with sepsis: A$43,345?±?46,263 (€35,109?±?35,043) versus 34,844?±?38,281 (€28,223?±?31,007), mean difference $8501 (€6885), 95% CI $4342–12,660 (€3517?±?10,254), p?<?0.001 as was the total cost of hospital treatment to 2 years: A$74,120?±?60,750 (€60,037?±?49,207) versus A$65,806?±?59,856 (€53,302?±?48,483), p?=?0.005.

Conclusions

Critically ill patients with sepsis have higher healthcare resource use and costs but similar survival and HRQoL compared to matched patients without sepsis.

     

To Explore a Representative Hypoxic Parameter to Predict the Treatment Response and Prognosis Obtained by [<Superscript>18</Superscript>F]FMISO-PET in Patients with Non-small Cell Lung Cancer

Purpose

To explore a representative hypoxic parameter to predict the treatment response and prognosis for [¹⁸F]fluoromisonidazole ([¹⁸F]FMISO) positron emission tomography (PET)/X-ray computed tomography (CT) in patients with non-small cell lung cancer (NSCLC).

Procedures

Twenty-nine patients with NSCLC underwent FMISO-PET scans before chemoradiotherapy (CRT). The maximum standard uptake values (SUVmax) in the tumor, normal lung, aortic arch, and vertical ridge muscle were measured, and the tumor-to-lung (T/L) ratios, tumor-to-blood (T/B) ratios, ands tumor-to-muscle (T/M) ratios were calculated and analyzed. Fractional hypoxic volume (FHV) was expressed as percentage of hypoxic volume.

Results

SUVmax, T/L ratio, T/B ratio, and FHV were all significantly different between the responders and the non-responders (SUVmax, 2.07?±?0.53 vs. 2.61?±?0.69, P?=?0.026; T/L ratio, 3.16?±?0.85 vs. 4.09?±?1.46, P?=?0.047; T/B ratio, 1.27?±?0.20 vs. 1.48?±?0.32, P?=?0.042; 38.92?±?18.47 vs. 52.91?±?11.29 %, P?=?0.020). However, the T/M ratio was not significantly different between the two populations (1.46?±?0.31 vs. 1.67?±?0.33, P?=?0.098). The correlation ratio between hypoxic parameters and treatment responses ranged from high to low as FHV (r?=?0.412); SUVmax (r?=?0.400); T/L ratio (r?=?0.379), P?<?0.05; and T/B ratio (r?=?0.355), P?=?0.059. According to the area under curve (AUC) to predict response, the hypoxic parameters were arranged as FHV (AUC?=?0.748), SUVmax (AUC?=?0.731), T/L ratio (AUC?=?0.719), and T/B ratio (AUC?=?0.705). Binary logistic regression analyses showed that FHV was the only independent predictor for treatment response with the P value of 0.038. In the progression-free survival (PFS) prediction, both FHV and SUVmax reached statistical significance by Kaplan–Meier plots (FHV, 46.99 %, P?=?0.010; SUVmax, 1.99, P?=?0.046) while only FHV was the independent prognostic factor in multivariate analysis by Cox proportional hazard model (P?=?0.037).

Conclusion

FHV may be a representative hypoxic parameter to predict the CRT response and PFS in patients with NSCLC.

     

„Foam rolling“ und Wirbelsäulenbeweglichkeit – eine randomisierte kontrollierte Pilotstudie

Background

Despite limited evidence and little knowledge about underlying mechanisms or even potential risks, foam rolling (FR) has become a widely used tool for fitness and health purposes. Improvements in lower limb flexibility have been described, but there is a paucity of information for the spine.

Purpose

This pilot study aimed to investigate the effects of FR on trunk and spinal flexion and axial rotation in healthy subjects.

Methods

Spinal flexibility at maximal trunk flexion (sit and reach test) and maximal vertebral axial rotation (segments L1 and T4, dynamic video rasterstereography) was assessed in a randomized controlled repeated measures design (experimental and waiting control conditions separated by 1 week) before and after FR or a respective waiting time (control) in a sample of 19 active healthy females (age 26.1?±?3.6 years, body mass index 22.3?±?2.6?kg/m²). FR consisted of 2 repetitions (each 3?min with 60?s rest) for the paraspinal and lateral back muscles (10 roll cyles/min, average pressure approximately two thirds of body weight).

Results

We found a significant 2?cm increase in the sit and reach test results (p?<?0.001), which was, however, independent of the FR treatment (p?=?0.910). Vertebral rotation (L1, T4) did not change significantly (p?=?0.290–0.941). Although we observed 2?degree increases on average for the FR condition only, the time?×?treatment interactions did not indicate an FR effect (p?=?0.261–0.368).

Conclusion

Commonly accepted evidence for increases in lower limb flexibility after FR cannot be confirmed for spinal mobility after a single treatment in healthy active young women. The technical approach using dynamic rasterstereography to quantify axial spinal rotation appears to be promising for future FR investigations targeting patients with back complaints, provided methodical adaptations are taken into account.

     

Effects of heat stress and dehydration on cognitive function in elite female field hockey players

Background

It has previously been suggested that heat exposure and hypohydration have negative effects on cognitive performance, which may impact upon sporting performance. The aim of the present study was to examine the independent effects of heat stress and hypohydration on cognitive performance in elite female field hockey players.

Methods

Eight unacclimatised elite field hockey players (age: 22?±?3 y; height: 1.68?±?0.05 m; body mass: 63.1?±?6.0 kg) completed a cognitive test battery before and after 50 min of field hockey specific exercise on a treadmill in four experimental trials; two in hot conditions (33.3?±?0.1 °C), and two in moderate (16.0?±?3.0 °C), both with and without ad libitum water intake.

Results

On the visual search test, participants were faster overall in the heat (1941 vs. 2104 ms, p?=?0.001). Response times were quicker in the heat on the Sternberg paradigm (463 vs. 473 ms, p?=?0.024) and accuracy was improved (by 1.9%, p?=?0.004). There was no effect of hydration status on any of the markers of cognitive function.

Conclusions

Overall, the findings suggest that in elite field hockey players exposure to heat enhances response times and/or accuracy on a battery of cognitive function tests. However, hypohydration does not appear to affect cognitive performance in elite field hockey players.

     

Screening for psychological distress in follow-up care to identify head and neck cancer patients with untreated distress

Purpose

The purpose of the study is to investigate screening in follow-up care to identify head and neck cancer (HNC) patients with untreated psychological distress.

Methods

From November 2009 until December 2012, we investigated the use of OncoQuest (a touch screen computer system to monitor psychological distress (Hospital Anxiety and Depression Scale (HADS)) and quality of life (HRQOL; EORTC QLQ-C30 and H&N35 module) in routine follow-up care. Patients who screened positive for psychological distress (HADS-T >14, HADS-A >7, or HADS-D >7) were asked whether they received psychological or psychiatric treatment.

Results

During the study period of 37 months, OncoQuest was used by 720 individual HNC patients, of whom 714 had complete HADS data. Psychological distress was present in 206 patients (29 %). Of those patients who fulfilled in- and exclusion criteria (n?=?137), 25 received psychological treatment (18 %). Receipt of psychological treatment was significantly related to a higher score on the HADS total scale (19.6 vs. 16.9; p?=?0.019), a lower (worse) score on the EORTC QLQ-C30 scale emotional functioning (46.0 vs. 58.6; p?=?0.023), a higher (worse) score on fatigue (58.2 vs. 46.4; p?=?0.032), problems with sexuality (44.1 vs. 34.4; p?=?0.043), oral pain (43.8 vs. 28.8; p?=?0.011) and speech problems (37.0 vs. 25.3; p?=?0.042).

Conclusions

Screening for psychological distress via OncoQuest is beneficial because 82 % of HNC patients identified with an increased level of distress who do not yet receive mental treatment were identified. Patients who did receive treatment reported more distress and worse quality of life, which may be explained because patients with more severe problems maybe more inclined to seek help or might be detected easier by caregivers and referred to supportive care more often.

     

Apnoeic oxygenation via high-flow nasal cannula oxygen combined with non-invasive ventilation preoxygenation for intubation in hypoxaemic patients in the intensive care unit: the single-centre,blinded, randomised controlled OPTINIV trial

Purpose

High-flow nasal cannula oxygen (HFNC) has the potential to provide apnoeic oxygenation. We decided to assess in a proof-of-concept study whether the addition of HFNC to non-invasive ventilation (NIV) could reduce oxygen desaturation during intubation, compared with NIV alone for preoxygenation, in severely hypoxaemic intensive care unit (ICU) patients with respiratory failure.

Methods

We conducted a randomised, controlled, single-centre trial with assessor-blinded outcome assessment in patients admitted to the ICU. Hypoxaemic patients requiring orotracheal intubation for respiratory failure were randomised to receive preoxygenation using HFNC [flow = 60 L/min, fraction of inspired oxygen (FiO₂) = 100 %] combined with NIV (pressure support = 10 cmH₂O, positive end-expiratory pressure = 5 cmH₂O, FiO₂ = 100 %) in the intervention group or NIV alone in the reference group prior to intubation. The primary outcome was the lowest oxygen saturation (SpO₂) during the intubation procedure. Secondary outcomes were intubation-related complications and ICU mortality.

Results

Between July 2015 and February 2016, we randomly assigned 25 and 24 patients to the intervention and reference groups, respectively. In both groups the main reasons for respiratory failure were pneumonia and ARDS. During the intubation procedure, the lowest SpO₂ values were significantly higher in the intervention group than in the reference group [100 (95–100) % vs. 96 (92–99) %, p = 0.029]. After exclusion of two patients from analysis for protocol violation, no (0 %) patients in the intervention group and five (21 %) patients in the reference group had SpO₂ below 80 % (p = 0.050). We recorded no significant difference between the groups in intubation-related complications or ICU mortality.

Conclusions

A novel strategy for preoxygenation in hypoxaemic patients, adding HFNC for apnoeic oxygenation to NIV prior to orotracheal intubation, may be more effective in reducing the severity of oxygen desaturation than the reference method using NIV alone.

     

Practical and clinical utility of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a post hoc analysis of the randomized,sham-controlled,double-blind PRESTO trial

Background

The PRESTO study of non-invasive vagus nerve stimulation (nVNS; gammaCore®) featured key primary and secondary end points recommended by the International Headache Society to provide Class I evidence that for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free 2 h post stimulation. Here, we examined additional data from PRESTO to provide further insights into the practical utility of nVNS by evaluating its ability to consistently deliver clinically meaningful improvements in pain intensity while reducing the need for rescue medication.

Methods

Patients recorded pain intensity for treated migraine attacks on a 4-point scale. Data were examined to compare nVNS and sham with regard to the percentage of patients who benefited by at least 1 point in pain intensity. We also assessed the percentage of attacks that required rescue medication and pain-free rates stratified by pain intensity at treatment initiation.

Results

A significantly higher percentage of patients who used acute nVNS treatment (n?=?120) vs sham (n?=?123) reported a?≥?1-point decrease in pain intensity at 30 min (nVNS, 32.2%; sham, 18.5%; P?=?0.020), 60 min (nVNS, 38.8%; sham, 24.0%; P?=?0.017), and 120 min (nVNS, 46.8%; sham, 26.2%; P?=?0.002) after the first attack. Similar significant results were seen when assessing the benefit in all attacks. The proportion of patients who did not require rescue medication was significantly higher with nVNS than with sham for the first attack (nVNS, 59.3%; sham, 41.9%; P?=?0.013) and all attacks (nVNS, 52.3%; sham, 37.3%; P?=?0.008). When initial pain intensity was mild, the percentage of patients with no pain after treatment was significantly higher with nVNS than with sham at 60 min (all attacks: nVNS, 37.0%; sham, 21.2%; P?=?0.025) and 120 min (first attack: nVNS, 50.0%; sham, 25.0%; P?=?0.018; all attacks: nVNS, 46.7%; sham, 30.1%; P?=?0.037).

Conclusions

This post hoc analysis demonstrated that acute nVNS treatment quickly and consistently reduced pain intensity while decreasing rescue medication use. These clinical benefits provide guidance in the optimal use of nVNS in everyday practice, which can potentially reduce use of acute pharmacologic medications and their associated adverse events.

Trial registration

ClinicalTrials.gov identifier: NCT02686034.

     

Acute hypoxemic respiratory failure in immunocompromised patients: the Efraim multinational prospective cohort study

Background

In immunocompromised patients with acute hypoxemic respiratory failure (ARF), initial management aims primarily to avoid invasive mechanical ventilation (IMV).

Methods

To assess the impact of initial management on IMV and mortality rates, we performed a multinational observational prospective cohort study in 16 countries (68 centers).

Results

A total of 1611 patients were enrolled (hematological malignancies 51.9%, solid tumors 35.2%, systemic diseases 17.3%, and solid organ transplantation 8.8%). The main ARF etiologies were bacterial (29.5%), viral (15.4%), and fungal infections (14.7%), or undetermined (13.2%). On admission, 915 (56.8%) patients were not intubated. They received standard oxygen (N = 496, 53.9%), high-flow oxygen (HFNC, N = 187, 20.3%), noninvasive ventilation (NIV, N = 153, 17.2%), and NIV + HFNC (N = 79, 8.6%). Factors associated with IMV included age (hazard ratio = 0.92/year, 95% CI 0.86–0.99), day-1 SOFA (1.09/point, 1.06–1.13), day-1 PaO₂/FiO₂ (1.47, 1.05–2.07), ARF etiology (Pneumocystis jirovecii pneumonia (2.11, 1.42–3.14), invasive pulmonary aspergillosis (1.85, 1.21–2.85), and undetermined cause (1.46, 1.09–1.98). After propensity score matching, HFNC, but not NIV, had an effect on IMV rate (HR = 0.77, 95% CI 0.59–1.00, p = 0.05). ICU, hospital, and day-90 mortality rates were 32.4, 44.1, and 56.4%, respectively. Factors independently associated with hospital mortality included age (odds ratio = 1.18/year, 1.09–1.27), direct admission to the ICU (0.69, 0.54–0.87), day-1 SOFA excluding respiratory score (1.12/point, 1.08–1.16), PaO₂/FiO₂ < 100 (1.60, 1.03–2.48), and undetermined ARF etiology (1.43, 1.04–1.97). Initial oxygenation strategy did not affect mortality; however, IMV was associated with mortality, the odds ratio depending on IMV conditions: NIV + HFNC failure (2.31, 1.09–4.91), first-line IMV (2.55, 1.94–3.29), NIV failure (3.65, 2.05–6.53), standard oxygen failure (4.16, 2.91–5.93), and HFNC failure (5.54, 3.27–9.38).

Conclusion

HFNC has an effect on intubation but not on mortality rates. Failure to identify ARF etiology is associated with higher rates of both intubation and mortality. This suggests that in addition to selecting the appropriate oxygenation device, clinicians should strive to identify the etiology of ARF.

     

Polymyxin B hemoperfusion in endotoxemic septic shock patients without extreme endotoxemia: a post hoc analysis of the EUPHRATES trial

Purpose

The EUPHRATES trial examined the impact of polymyxin B hemoperfusion (PMX) on mortality in patients with septic shock and endotoxemia, defined as EAA?≥?0.60. No difference was found in 28-day all-cause mortality. However, the trial showed that in some patients with septic shock the burden of endotoxin activity was extreme (EAA?≥?0.9). In a post hoc analysis, we evaluated the impact of PMX use in patients with septic shock and endotoxin activity measured between 0.6–0.89.

Methods

Post-hoc analysis of the EUPHRATES trial for the 194 patients with EAA?≥?0.6–0.89 who completed two treatments (PMX or sham). The primary end point was mortality at 28 days adjusted for APACHE II score and baseline mean arterial pressure (MAP). Additional end points included changes in MAP, cumulative vasopressor index (CVI), median EAA reduction, ventilator-free days (VFD), dialysis-free days (DFD) and hospital length of stay. Subpopulations analyzed were site and type of infection and those with norepinephrine dose > 0.1 mcg/kg/min at baseline.

Results

At 28 days, 23 patients of 88 (26.1%) in the PMX group died versus 39 of 106 (36.8%) in the sham group [risk difference 10.7%, OR 0.52, 95% CI (0.27, 0.99), P?=?0.047]. When unadjusted for baseline variables, P?=?0.11. The 28-day survival time in the PMX group was longer than for the sham group [HR 0.56 (95% CI 0.33, 0.95) P?=?0.03]. PMX treatment compared with sham showed greater change in MAP [median (IQR) 8 mmHg (??0.5, 19.5) vs. 4 mmHg (??4.0, 11) P?=?0.04] and VFD [median (IQR) 20 days (0.5, 23.5) vs. 6 days (0, 20), P?=?0.004]. There were no significant differences in other end points. There was a significant difference in mortality in PMX-treated patients with no bacterial growth on culture [PMX, 6/30 (20%) vs. sham, 13/31 (41.9%), P?=?0.005]. The median EAA change in the population was ??12.9% (range: increase 49.2%–reduction 86.3%). The mortality in the above median EAA change group was PMX: 6/38 (15.7%) vs. sham 15/49 (30.6%), P?=?0.08.

Conclusions

These hypothesis-generating results, based on an exploratory post hoc analysis of the EUPHRATES trial, suggest measurable responses in patients with septic shock and an EAA?≥?0.6 to 0.89 on changes in mean arterial pressure, ventilator-free days and mortality.

Trial registration

Clinicaltrials.gov Identifier: NCT01046669. Funding Spectral Medical Incorporated.

     

Lack of agreement between thermodilution and electrical velocimetry cardiac output measurements

Objective

The modified algorithm for the non-invasive determination of cardiac output (CO) by electrical bioimpedance—electrical velocimetry (EV^®)—has been reported to give reliable results in comparison with echocardiography and pulmonary arterial thermodilution (PA-TD) in patients either before or after cardiac surgery. The present study was designed to determine whether EV^®-CO measurements reflect intraindividual changes in CO during cardiac surgery.

Design

Prospective, observational study.

Setting

Operating room (OR) and intensive care unit (ICU) of a university hospital.

Patients

Twenty-nine patients undergoing elective cardiac surgery.

Interventions

None.

Measurements

CO was determined simultaneously by PA-TD and EV^® after induction of anesthesia (t1) and 4.9?±?3.5?h after ICU admission (t2).

Results

TD-CO was 3.9?±?1.4 and 5.4?±?1.1 l/min at t1 and t2 (?p?®-CO was 4.3?±?1.1 and 4.9?±?1.5 l/min at t1 and t2 (?p?=?0.013). Bland–Altman analysis showed a bias of ?0.4 l/min and 0.4 l/min and a precision of 3.2 and 3.6 l/min (34.3% and 67.4%) at t1 and t2, respectively. Analysis of the individual pre- to postoperative changes in CO with both methods revealed bidirectional changes in n?=?12 patients and unidirectional changes with a difference greater than 50% and less than 50% in n?=?9 and n?=?8 patients, respectively.

Conclusions

The disagreement between PA-TD and EV^®-CO measurements after anesthesia induction and after ICU admission, as well as the fact that thoracic bioimpedance did not adequately reflect pre- to postoperative changes in CO, questions the reliability of EV^®-CO measurements in cardiac surgery patients and contrasts sharply with previous studies.

     

Transthoracic echocardiography and mortality in sepsis: analysis of the MIMIC-III database

Purpose

While the use of transthoracic echocardiography (TTE) in the ICU is rapidly expanding, the contribution of TTE to altering patient outcomes among ICU patients with sepsis has not been examined. This study was designed to examine the association of TTE with 28-day mortality specifically in that population.

Methods and results

The MIMIC-III database was employed to identify patients with sepsis who had and had not received TTE. The statistical approaches utilized included multivariate regression, propensity score analysis, doubly robust estimation, the gradient boosted model, and an inverse probability-weighting model to ensure the robustness of our findings. Significant benefit in terms of 28-day mortality was observed among the TTE patients compared to the control (no TTE) group (odds ratio?=?0.78, 95% CI 0.68–0.90, p?<?0.001). The amount of fluid administered (2.5 vs. 2.1 L on day 1, p?<?0.001), use of dobutamine (2% vs. 1%, p?=?0.007), and the maximum dose of norepinephrine (1.4 vs. 1 mg/min, p?=?0.001) were significantly higher for the TTE patients. Importantly, the TTE patients were weaned off vasopressors more quickly than those in the no TTE group (vasopressor-free days on day 28 of 21 vs. 19, p?=?0.004).

Conclusion

In a general population of critically ill patients with sepsis, use of TTE is associated with an improvement in 28-day mortality.

     

Procalcitonin algorithm to guide initial antibiotic therapy in acute exacerbations of COPD admitted to the ICU: a randomized multicenter study

Purpose

To compare the efficacy of an antibiotic protocol guided by serum procalcitonin (PCT) with that of standard antibiotic therapy in severe acute exacerbations of COPD (AECOPDs) admitted to the intensive care unit (ICU).

Methods

We conducted a multicenter, randomized trial in France. Patients experiencing severe AECOPDs were assigned to groups whose antibiotic therapy was guided by (1) a 5-day PCT algorithm with predefined cutoff values for the initiation or stoppage of antibiotics (PCT group) or (2) standard guidelines (control group). The primary endpoint was 3-month mortality. The predefined noninferiority margin was 12%.

Results

A total of 302 patients were randomized into the PCT (n?=?151) and control (n?=?151) groups. Thirty patients (20%) in the PCT group and 21 patients (14%) in the control group died within 3 months of admission (adjusted difference, 6.6%; 90% CI ??0.3 to 13.5%). Among patients without antibiotic therapy at baseline (n?=?119), the use of PCT significantly increased 3-month mortality [19/61 (31%) vs. 7/58 (12%), p?=?0.015]. The in-ICU and in-hospital antibiotic exposure durations, were similar between the PCT and control group (5.2?±?6.5 days in the PCT group vs. 5.4?±?4.4 days in the control group, p?=?0.85 and 7.9?±?8 days in the PCT group vs. 7.7?±?5.7 days in the control group, p?=?0.75, respectively).

Conclusion

The PCT group failed to demonstrate non-inferiority with respect to 3-month mortality and failed to reduce in-ICU and in-hospital antibiotic exposure in AECOPDs admitted to the ICU.

     

Effects of adenosine and regadenoson on hemodynamics measured using cardiovascular magnetic resonance imaging

Background

Adenosine or regadenoson vasodilator stress cardiovascular magnetic resonance (CMR) is an effective non-invasive strategy for evaluating symptomatic coronary artery disease. Vasodilator injection typically precedes ventricular functional sequences to efficiently reduce overall scanning times, though the effects of vasodilators on CMR-derived ventricular volumes and function are unknown.

Methods

We prospectively enrolled 25 healthy subjects to undergo consecutive adenosine and regadenoson administration. Short axis CINE datasets were obtained on a 1.5 T scanner following adenosine (140mcg/kg/min IV for 6 min) and regadenoson (0.4 mg IV over 10 s) at baseline, immediately following administration, at 5 min intervals up to 15 min. Hemodynamic response, bi-ventricular volumes and ejection fractions were determined at each time point.

Results

Peak heart rate was observed early following administration of both adenosine and regadenoson. Heart rate returned to baseline by 10 min post-adenosine while remaining elevated at 15 min post-regadenoson (p?=?0.0015). Left ventricular (LV) ejection fraction (LVEF) increased immediately following both vasodilators (p?<?0.0001 for both) and returned to baseline following adenosine by 10 min (p?=?0.8397). Conversely, LVEF following regadenoson remained increased at 10 min (p?=?0.003) and 15 min (p?=?0.0015) with a mean LVEF increase at 15 min of 4.2?±?1.3%. Regadenoson resulted in a similar magnitude reduction in both LV end-diastolic volume index (LVEDVi) and LV end-systolic volume index (LVESVi) at 15 min whereas LVESVi resolved at 15 min following adenosine and LVEDVi remained below baseline values (p?=?0.52).

Conclusions

Regadenoson and adenosine have significant and prolonged impact on ventricular volumes and LVEF. In patients undergoing vasodilator stress CMR where ventricular volumes and LVEF are critical components to patient care, ventricular functional sequences should be performed prior to vasodilator use or consider the use of aminophylline in the setting of regadenoson. Additionally, heart rate resolution itself is not an effective surrogate for return of ventricular volumes and LVEF to baseline.

     

Oxygen treatment for cluster headache attacks at different flow rates: a double-blind,randomized, crossover study

Background

Cluster headache attacks can, in many patients, be successfully treated with oxygen via a non-rebreather mask. In previous studies oxygen at flow rates of both 7 L/min and 12 L/min was shown to be effective. The aim of this study was to compare the effect of 100% oxygen at different flow rates for the treatment of cluster headache attacks.

Methods

In a double-blind, randomized, crossover study, oxygen naïve cluster headache patients, treated attacks with oxygen at 7 and 12 L/min. The primary outcome measure was the percentage of attacks after which patients (treating at least 2 attacks/day) were painfree after 15 min, in the first two days of the study. Secondary outcome measures were percentage of successfully treated attacks, percentage of attacks after which patients were painfree, drop in VAS score and patient preference in all treatment periods (14 days).

Results

Ninety-eight patients were enrolled, 70 provided valid data, 56 used both flow rates. These 56 patients recorded 604 attacks, eligible for the primary analysis. An exploratory analysis was conducted using all eligible attacks of 70 patients who provided valid data. We could only include 5 patients, treating 27 attacks on the first two days of the study, for our primary outcome, which did not show a significant difference (p?=?0.180). Patients tended to prefer 12 L/min (p?=?0.005). Contradicting this result, more patients were painfree using 7 L/min (p?=?0.039). There were no differences in side effects or in our other secondary outcome measures. The exploratory analysis showed an odds ratio of being painfree using 12 L/min of 0.73 (95% CI 0.52–1.02) compared to 7 L/min (p?=?0.061) as scored on a 5-point scale. The average drop in score on this 5-point scale, however, was equal between groups. Also slightly more patients noticed, no or not much, relief on 7 L/min, and found 12 L/min to be effective in all their attacks.

Conclusion

There is lack of evidence to support differences in the effect of oxygen at a flow rate of 12 L/min compared to 7 L/min. More patients were painfree using 7 L/min, but our other outcome measures did not confirm a difference in effect between flow rates. As most patients prefer 12 L/min and treatments were equally safe, this could be used in all patients. It might be more cost-effective, however, to start with 7 L/min and, if ineffective, to switch to 12 L/min.

Trial registration

European Union Clinical Trials Register (2012–003648-59), registered 1 October 2012. Dutch Trial Register (NTR3801), registered 14 January 2013.

     

Adaptive leadership curriculum for Indian paramedic trainees

Background

Paramedic trainees in developing countries face complex and chaotic clinical environments that demand effective leadership, communication, and teamwork. Providers must rely on non-technical skills (NTS) to manage bystanders and attendees, collaborate with other emergency professionals, and safely and appropriately treat patients. The authors designed a NTS curriculum for paramedic trainees focused on adaptive leadership, teamwork, and communication skills critical to the Indian prehospital environment.

Methods

Forty paramedic trainees in the first academic year of the 2-year Advanced Post-Graduate Degree in Emergency Care (EMT-paramedic equivalent) program at the GVK-Emergency Management and Research Institute campus in Hyderabad, India, participated in the 6-day leadership course. Trainees completed self-assessments and delivered two brief video-recorded presentations before and after completion of the curriculum.

Results

Independent blinded observers scored the pre- and post-intervention presentations delivered by 10 randomly selected paramedic trainees. The third-party judges reported significant improvement in both confidence (25 %, p?<?0.01) and body language of paramedic trainees (13 %, p?<?0.04). Self-reported competency surveys indicated significant increases in leadership (2.6 vs. 4.6, p?<?0.001, d?=?1.8), public speaking (2.9 vs. 4.6, p?<?0.001, d?=?1.4), self-reflection (2.7 vs. 4.6, p?<?0.001, d?=?1.6), and self-confidence (3.0 vs. 4.8, p?<?0.001, d?=?1.5).

Conclusions

Participants in a 1-week leadership curriculum for prehospital providers demonstrated significant improvement in self-reported NTS commonly required of paramedics in the field. The authors recommend integrating focused NTS development curriculum into Indian paramedic education and further evaluation of the long term impacts of this adaptive leadership training.

     

Estimation of weight in adults from height: a novel option for a quick bedside technique

Purpose

In critical care situations, there are often neither the means nor the time to weigh each patient before administering strict weight-based drugs/procedures. A convenient, quick and accurate method is a priority in such circumstances for safety and effectiveness in emergent interventions as none exists in adults while those available are complex and yet to be validated. We aimed to study the correlation and accuracy of a quick bedside method of weight estimation in adults using height.

Method

The technique is estimated body weight—eBW(kg)?=?(N ??1)100, where ‘N’ is the measured height in metres.Adult undergraduates were enrolled 10/09/2015. Their heights and weights were measured while the formula was used to obtain the estimated weight. The SPSS version 21.0, Chicago, IL, USA was utilised for data analysis.

Results

We analysed 122 participants aged 21–38?years with height?=?1.55?m–1.95?m. The actual body weight range?=?48.0?kg–91.0 kg, mean?=?65.3?kg?±?9.7?kg and S.E.?=?2.0 while eBW?=?55 kg–95 kg, mean?=?69.1?kg?±?8.4?kg and S.E.?=?1.5. On BMI classes, a positive predictive value of 94.7% for the ‘normal’ category and 95.5% for ‘overweight’.Correlation coefficient at 99% confidence interval yielded (r)?=?+?1, (P?=?0.000) while the linear regression coefficient (r²)?=?+?1 at 95% confidence interval (P?=?0.000).The strength of agreement/precision was established by the Bland-Altman plot at 95%?±?2?s (P?=?0.000) and kappa statistic with value?=?0. 618.

Conclusion

This unprecedented statistical characterisation of the two weight estimate measures to have a good agreement scientifically proposes the utility of our method with the formula eBW(kg)?=?100(N?1) in critical care and ATLS protocol.

     

Prediction of tumor response after neoadjuvant chemoradiotherapy in rectal cancer using <Superscript>18</Superscript>fluorine-2-deoxy-<Emphasis Type="SmallCaps">d</Emphasis>-glucose positron emission tomography–computed tomography and serum carcinoembryonic antigen: a prospective study

Purpose

To investigate the association between ¹⁸fluorine-2-deoxy-d-glucose positron emission tomography–computed tomography (¹⁸F-FDG PET/CT) parameters, serum carcinoembryonic antigen (CEA), and tumor response in patients with rectal cancer receiving neoadjuvant chemoradiotherapy (nCRT).

Methods

Sixty-four patients with T3-4 and/or node-positive rectal cancer receiving nCRT followed by surgery were prospectively studied. PET/CT was performed before, and in 28 patients, both before and after nCRT. The pre-/post-nCRT maximum standardized uptake (SUVmax) values, differences between pre-/post-nCRT SUVmax (?SUVmax), response index of SUVmax (RI-SUVmax), mean standardized uptake value (SUVmean), metabolic tumor volume (MTV), total lesion glycolysis (TLG), and CEA were measured. The ability of PET/CT parameters and CEA to predict Mandard’s tumor regression grade (TRG) and pathological complete remission (pCR) were evaluated.

Results

31 patients were identified as responders (TRG 1–2), and 19 exhibited pCR. For responders, significant differences were found for ΔSUVmax (24.88 vs. 15.39 g/ml, p = 0.037), RI-SUVmax (0.76 vs. 0.63, p = 0.025), ΔSUVmean (14.43 vs. 8.65 g/ml, p = 0.029), RI-SUVmean (0.77 vs. 0.63, p = 0.011), CEA-pre (6.30 vs. 27.86 μg/L, p < 0.001), CEA-post (2.22 vs. 5.49 μg/L, p = 0.002), ΔCEA (4.08 vs. 23.13 μg/L, p < 0.001), and RI-CEA (0.25 vs. 0.55, p = 0.002). Differences between pCR and non-pCR patients were noted as RI-SUVmean (0.77 vs. 0.65, p = 0.043), MTV-pre (9.87 vs. 14.62 cm³, p = 0.045), CEA-pre (5.62 vs. 22.27 μg/L, p = 0.002), CEA-post (1.95 vs. 4.72 μg/L, p = 0.001), and ΔCEA (3.68 vs. 17.99 μg/L, p = 0.013). Receiver operating characteristic analysis revealed that RI-SUVmean exhibited the greatest accuracy in predicting responders, whereas CEA-post and ΔCEA exhibited the greatest accuracy in predicting pCR.

Conclusions

¹⁸F-FDG PET/CT parameters and CEA are accurate tools for predicting tumor response to nCRT in rectal cancer.