Ultra-lung-protective ventilation and biotrauma in severe ARDS patients on veno-venous extracorporeal membrane oxygenation: a randomized controlled study.

BACKGROUND: Ultra-lung-protective ventilation may be useful during veno-venous extracorporeal membrane oxygenation (vv-ECMO) for severe acute respiratory distress syndrome (ARDS) to minimize ventilator-induced lung injury and to facilitate lung recovery. The objective was to compare pulmonary and systemic biotrauma evaluated by numerous biomarkers of inflammation, epithelial, endothelial injuries, and lung repair according to two ventilator strategies on vv-ECMO. METHODS: This is a prospective randomized controlled study. Patients were randomized to receive during 48 h either ultra-lung-protective ventilation combining very low tidal volume (1-2 mL/kg of predicted body weight), low respiratory rate (5-10 cycles per minute), positive expiratory transpulmonary pressure, and 16 h of prone position or lung-protective-ventilation which followed the ECMO arm of the EOLIA trial (control group). RESULTS: The primary outcome was the alveolar concentrations of interleukin-1-beta, interleukin-6, interleukin-8, surfactant protein D, and blood concentrations of serum advanced glycation end products and angiopoietin-2 48 h after randomization. Enrollment was stopped for futility after the inclusion of 39 patients. Tidal volume, respiratory rate, minute ventilation, plateau pressure, and mechanical power were significantly lower in the ultra-lung-protective group. None of the concentrations of the pre-specified biomarkers differed between the two groups 48 h after randomization. However, a trend to higher 60-day mortality was observed in the ultra-lung-protective group compared to the control group (45 vs 17%, p = 0.06). CONCLUSIONS: Despite a significant reduction in the mechanical power, ultra-lung-protective ventilation during 48 h did not reduce biotrauma in patients with vv-ECMO-supported ARDS. The impact of this ventilation strategy on clinical outcomes warrants further investigation. Trial registration Clinical trial registered with www. CLINICALTRIALS: gov ( NCT03918603 ). Registered 17 April 2019.

Effects of a Multimodal Program Including Simulation on Job Strain Among Nurses Working in Intensive Care Units: A Randomized Clinical Trial.

Importance: Nurses working in an intensive care unit (ICU) are exposed to occupational stressors that can increase the risk of stress reactions, long-term absenteeism, and turnover. Objective: To evaluate the effects of a program including simulation in reducing work-related stress and work-related outcomes among ICU nurses. Design, Setting, and Participants: Multicenter randomized clinical trial performed at 8 adult ICUs in France from February 8, 2016, through April 29, 2017. A total of 198 ICU nurses were included and followed up for 1 year until April 30, 2018. Interventions: The ICU nurses who had at least 6 months of ICU experience were randomized to the intervention group (n = 101) or to the control group (n = 97). The nurses randomized to the intervention group received a 5-day course involving a nursing theory recap and situational role-play using simulated scenarios (based on technical dexterity, clinical approach, decision making, aptitude to teamwork, and task prioritization), which were followed by debriefing sessions on attitude and discussion of practices. Main Outcomes and Measures: The primary outcome was the prevalence of job strain assessed by combining a psychological demand score greater than 21 (score range, 9 [best] to 36 [worst]) with a decision latitude score less than 72 (score range, 24 [worst] to 96 [best]) using the Job Content Questionnaire and evaluated at 6 months. There were 7 secondary outcomes including absenteeism and turnover. Results: Among 198 ICU nurses who were randomized (95 aged ≤30 years [48%] and 115 women [58%]), 182 (92%) completed the trial for the primary outcome. The trial was stopped for efficacy at the scheduled interim analysis after enrollment of 198 participants. The prevalence of job strain at 6 months was lower in the intervention group than in the control group (13% vs 67%, respectively; between-group difference, 54% [95% CI, 40%-64%]; P < .001). Absenteeism during the 6-month follow-up period was 1% in the intervention group compared with 8% in the control group (between-group difference, 7% [95% CI, 1%-15%]; P = .03). Four nurses (4%) from the intervention group left the ICU during the 6-month follow-up period compared with 12 nurses (12%) from the control group (between-group difference, 8% [95% CI, 0%-17%]; P = .04). Conclusions and Relevance: Among ICU nurses, an intervention that included education, role-play, and debriefing resulted in a lower prevalence of job strain at 6 months compared with nurses who did not undergo this program. Further research is needed to understand which components of the program may have contributed to this result and to evaluate whether this program is cost-effective. Trial Registration: ClinicalTrials.gov Identifier: NCT02672072.