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

This article by El Khamali and others was published inJAMA during November 2018.
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:  Multi-center 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.
The print copy of this issue JAMA is available in the Healthcare Library on D Level of Rotherham General Hospital.

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Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients without ARDS: A Randomized Clinical Trial.

This article by the Writing Group for the PReVENT Investigators was published in JAMA in November 2018.
Importance:  It remains uncertain whether invasive ventilation should use low tidal volumes in critically ill patients without acute respiratory distress syndrome (ARDS).
Objective:  To determine whether a low tidal volume ventilation strategy is more effective than an intermediate tidal volume strategy.
Design,Setting, and Participants:  A randomized clinical trial, conducted from September 1, 2014, through August 20, 2017,including patients without ARDS expected to not be extubated within 24 hours after start of ventilation from 6 intensive care units in the Netherlands.
Interventions:  Invasive ventilation using low tidal volumes(n = 477) or intermediate tidal volumes (n = 484).
Main Outcomes and Measures:  The primary outcome was the number of ventilator-free days and alive at day 28. Secondary outcomes included length of ICU and hospital stay; ICU, hospital, and 28- and 90-day mortality; and development of ARDS, pneumonia, severe atelectasis, orpneumothorax.
Results:  In total, 961 patients (65% male), with a median age of 68 years (interquartile range [IQR], 59-76), were enrolled. Atday 28, 475 patients in the low tidal volume group had a median of 21 ventilator-free days (IQR, 0-26), and 480 patients in the intermediate tidal volume group had a median of 21 ventilator-free days (IQR, 0-26) (mean difference, -0.27 [95% CI, -1.74 to 1.19]; P = .71). There was no significant difference in ICU (median, 6 vs 6 days; 0.39 [-1.09 to 1.89]; P = .58) and hospital (median, 14 vs 15 days; -0.60 [-3.52 to 2.31]; P = .68) length of stayor 28-day (34.9% vs 32.1%; hazard ratio [HR], 1.12 [0.90 to 1.40]; P = .30) and90-day (39.1% vs 37.8%; HR, 1.07 [0.87 to 1.31]; P = .54) mortality. There was no significant difference in the percentage of patients developing the following adverse events: ARDS (3.8% vs 5.0%; risk ratio [RR], 0.86 [0.59 to 1.24];P = .38), pneumonia (4.2% vs 3.7%; RR, 1.07 [0.78 to 1.47]; P = .67), severeatelectasis (11.4% vs 11.2%; RR, 1.00 [0.81 to 1.23]; P = .94), and pneumothorax (1.8% vs 1.3%; RR, 1.16 [0.73 to 1.84]; P = .55).  
Conclusions and Relevance:  In patients in the ICU without ARDS who were expected not to be extubated within 24 hours of randomization, a low tidal volume strategy did not result in a greater number of ventilator-free days than an intermediate tidal volume strategy.
The print copy of this issue JAMA is available in the Healthcare Library on D Level of Rotherham General Hospital.  The full text of the article should be available using a Rotherham NHS Athens password one month after publication via this link.

Effect of Protocolized Weaning With Early Extubation to Non-invasive Ventilation vs Invasive Weaning on Time to Liberation From Mechanical Ventilation Among Patients With Respiratory Failure: The Breathe Randomized Clinical Trial

This article by Perkins and colleagues was published in JAMA during November 2018.
Importance:  In adults in whom weaning from invasive mechanical ventilation is difficult, non-invasive ventilation may facilitate early liberation, but there is uncertainty about its effectiveness in a general intensive care patient population.
Objective:  To investigate among patients with difficulty weaning the effects of protocolized weaning with early extubation to non-invasive ventilation on time to liberation from ventilation compared with protocolized invasive weaning.
Design,Setting, and Participants:  Randomized,allocation-concealed, open-label, multicenter clinical trial enrolling patients between March 2013 and October 2016 from 41 intensive care units in the UK National Health Service. Follow-up continued until April 2017. Adults who received invasive mechanical ventilation for more than 48 hours and in whom a spontaneous breathing trial failed were enrolled.
Interventions:  Patients were randomized to receive either protocolized weaning via early extubation to non-invasive ventilation (n = 182)or protocolized standard weaning (continued invasive ventilation until successful spontaneous breathing trial, followed by extubation) (n = 182).
Main Outcomes and Measures:  Primary outcome was time from randomization to successful liberation from all forms of mechanical ventilation among survivors, measured in days, with the minimal clinically important difference defined as 1 day. Secondary outcomes were duration of invasive and total ventilation (days), reintubation or tracheostomyrates, and survival.
Results:  Among 364 randomized patients (mean age, 63.1[SD, 14.8] years; 50.5% male), 319 were evaluable for the primary effectiveness outcome (41 died before liberation, 2 withdrew, and 2 were discharged with ongoing ventilation). The median time to liberation was 4.3 days in the non-invasive group vs 4.5 days in the invasive group (adjusted hazard ratio, 1.1; 95% CI, 0.89-1.40).Competing risk analysis accounting for deaths had a similar result (adjusted hazard ratio, 1.1; 95% CI, 0.86-1.34). The non-invasive group received less invasive ventilation (median, 1 day vs 4 days; incidence rate ratio, 0.6; 95%CI, 0.47-0.87) and fewer total ventilator days (median, 3 days vs 4 days;incidence rate ratio, 0.8; 95% CI, 0.62-1.0). There was no significant difference in reintubation, tracheostomy rates, or survival. Adverse events occurred in 45 patients (24.7%) in the non-invasive group compared with 47(25.8%) in the invasive group.
Conclusions and Relevance:  Among patients requiring mechanical ventilation in whom a spontaneous breathing trial had failed, early extubation to non-invasive ventilation did not shorten time to liberation from any ventilation.
The print copy of this issue JAMA is available in the Healthcare Library on D Level of Rotherham General Hospital. 
The full text of the article should be available using a Rotherham NHS Athens password one month after publication via this link.

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

This article by El Kharnali and colleagues as part of the SISTRESSREA Study Group was published in JAMA during October 2018.
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.
The print copy of this issue JAMA is available in the Healthcare Library on D Level of Rotherham General Hospital.

Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without ARDS: A Randomized Clinical Trial

This article by the Writing Group for PReVENT Investigators was published in JAMA during October 2018.
Importance:  It remains uncertain whether invasive ventilation should use low tidal volumes in critically ill patients without acute respiratory distress syndrome (ARDS).
Objective:  To determine whether a low tidal volume ventilation strategy is more effective than an intermediate tidal volume strategy.
Design, Setting, and Participants:  A randomized clinical trial, conducted from September 1, 2014, through August 20, 2017, including patients without ARDS expected to not be extubated within 24 hours after start of ventilation from 6 intensive care units in the Netherlands.
Interventions:  Invasive ventilation using low tidal volumes (n = 477) or intermediate tidal volumes (n = 484).
Main Outcomes and Measures:  The primary outcome was the number of ventilator-free days and alive at day 28. Secondary outcomes included length of ICU and hospital stay; ICU, hospital, and 28- and 90-day mortality; and development of ARDS, pneumonia, severe atelectasis, or pneumothorax.
Results:  In total, 961 patients (65% male), with a median age of 68 years (interquartile range [IQR], 59-76), were enrolled. At day 28, 475 patients in the low tidal volume group had a median of 21 ventilator-free days (IQR, 0-26), and 480 patients in the intermediate tidal volume group had a median of 21 ventilator-free days (IQR, 0-26) (mean difference, -0.27 [95% CI, -1.74 to 1.19] P = .71). There was no significant difference in ICU (median, 6 vs 6 days; 0.39 [-1.09 to 1.89] ; P = .58) and hospital (median, 14 vs 15 days; -0.60 [-3.52 to 2.31]; P = .68) length of stay or 28-day (34.9% vs 32.1%; hazard ratio [HR], 1.12 [0.90 to 1.40]; P = .30) and 90-day (39.1% vs 37.8%; HR, 1.07 [0.87 to 1.31]; P = .54) mortality. There was no significant difference in the percentage of patients developing the following adverse events: ARDS (3.8% vs 5.0%; risk ratio [RR], 0.86 [0.59 to 1.24]; P = .38), pneumonia (4.2% vs 3.7%; RR, 1.07 [0.78 to 1.47]; P = .67), severe atelectasis (11.4% vs 11.2%; RR, 1.00 [0.81 to 1.23]; P = .94), and pneumothorax (1.8% vs 1.3%; RR, 1.16 [0.73 to 1.84]; P = .55).
Conclusions and Relevance:  In patients in the ICU without ARDS who were expected not to be extubated within 24 hours of randomization, a low tidal volume strategy did not result in a greater number of ventilator-free days than an intermediate tidal volume strategy.
The print copy of this issue JAMA is available in the Healthcare Library on D Level of Rotherham General Hospital.

Neuromuscular electrical stimulation combined with exercise decreases duration of mechanical ventilation in ICU patients: A randomized controlled trial.

This article by Dos Santos and colleagues was published in “Physiotherapy Theory and Practice”
Background:  Early mobilization can be employed to minimize the duration of intensive care. However, a protocol combining neuromuscular electrical stimulation (NMES) with early mobilization has not yet been tested in ICU patients. Our aim was to assess the efficacy of NMES, exercise (EX), and combined therapy (NMES + EX) on duration of mechanical ventilation (MV) in critically ill patients.
Methods:  The participants in this randomized double-blind trial were prospectively recruited within 24 hours following admission to the intensive care unit of a tertiary hospital. Eligible patients had 18 years of age or older; MV for less than 72 hours; and no known neuromuscular disease. Computer-generated permuted block randomization was used to assign patients to NMES, EX, NMES + EX, or standard care (control group). The main endpoint was duration of MV. Clinical characteristics were also evaluated and intention to treat analysis was employed.
Results:  One hundred forty-four patients were assessed for eligibility to participate in the trial, 51 of whom were enrolled and randomly allocated into four groups: 11 patients in the NMES group, 13 in the EX group, 12 in the NMES + EX group, and 15 in the control group (CG). Duration of MV (days) was significantly shorter in the combined therapy (5.7 ± 1.1) and NMEN (9.0 ± 7.0) groups in comparison to CG (14.8 ± 5.4).
Conclusions:  NMES + EX consisting of NMES and active EXs was well tolerated and resulted in shorter duration of MV in comparison to standard care or isolated therapy (NMES or EX alone).
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A cluster randomised, crossover, registry-embedded clinical trial of proton pump inhibitors versus histamine-2 receptor blockers for ulcer prophylaxis therapy in the intensive care unit (PEPTIC study): study protocol.

This article published in the September issue of Critical care and Resuscitation was produced by Australian and New Zealand Intensive Care Society Clinical Trials Group on behalf of the PEPTIC investigators.

Background:  The balance of risks and benefits with using proton pump inhibitors (PPIs) versus histamine-2 receptor blockers (H2RB) for stress ulcer prophylaxis in patients who are invasively ventilated in the intensive care unit (ICU) is uncertain.

Objective:  To describe the study protocol and statistical analysis plan for the Proton Pump Inhibitors versus Histamine-2 Receptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) study.

Design, setting and participants:  Protocol for a prospective, multicentre, randomised, open-label, cluster crossover, registry-embedded trial to be conducted in 50 ICUs in Australia, Canada, Ireland, New Zealand and the United Kingdom. The PEPTIC study will compare two approaches to stress ulcer prophylaxis in mechanically ventilated adults implemented at the level of the ICU. One approach is to use PPIs as the default therapy and the other approach is to use H2RBs as the default therapy when stress ulcer prophylaxis is prescribed. Each ICU, by random allocation, will use one approach for 6 months and will then switch to the opposite approach for the next 6 months. The PEPTIC study began recruitment in August 2016 and will complete recruitment in January 2019.

Main outcome measures:  The primary end point will be in-hospital mortality. Secondary outcomes include clinically significant upper gastrointestinal bleeding, Clostridium difficile infection, ICU length of stay and hospital length of stay.

Results and conclusions:  The PEPTIC study will compare the effect on in-hospital mortality of implementing, at the level of the ICU, the use of PPI as the preferred agent for stress ulcer prophylaxis in mechanically ventilated adults in the ICU with using H2RB as the preferred agent.

The full text of this article is available freely three months after publication via this link.  Library members can order individual articles via the Rotherham NHS Foundation Trust Library and Knowledge Service using the article requests online via this link.