Wireless communication and data transmission are playing an increasing role in the critical care environment. Early anecdotal reports of electromagnetic interference (EMI) with intensive care unit (ICU) equipment resulted in many institutions banning these devices. An increasing literature database has more clearly defined the risks of EMI. Restrictions to the use of mobile devices are being lifted, and it has been suggested that the benefits of improved communication may outweigh the small risks. However, increased use of cellular phones and ever changing communication technologies require ongoing vigilance by healthcare device manufacturers, hospitals and device users, to prevent potentially hazardous events due to EMI.
Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada Mount Sinai Hospital; and Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada *See also p. 663. Dr. Lapinsky's institution received funding from Ontario Thoracic Society, and he received funding from Sage Publishers. Dr. Al-Kalbani disclosed that he does not have any potential conflicts of interest.
Intensive Care Unit, Mount Sinai Hospital, Toronto, ON, Canada, Interdepartmental Division of Critical Care, University of Toronto, Toronto, ON, Canada The author has not disclosed any potential conflicts of interest.
Growing interest in microbial dysbiosis during critical illness has raised questions about the therapeutic potential of microbiome modification with probiotics. Prior randomized trials in this population suggest that probiotics reduce infection, particularly ventilator-associated pneumonia (VAP), although probiotic-associated infections have also been reported.
Objective
To evaluate the effect ofLactobacillus rhamnosusGG on preventing VAP, additional infections, and other clinically important outcomes in the intensive care unit (ICU).
Design, Setting, and Participants
Randomized placebo-controlled trial in 44 ICUs in Canada, the United States, and Saudi Arabia enrolling adults predicted to require mechanical ventilation for at least 72 hours. A total of 2653 patients were enrolled from October 2013 to March 2019 (final follow-up, October 2020).
Interventions
EnteralL rhamnosusGG (1 × 1010colony-forming units) (n = 1321) or placebo (n = 1332) twice daily in the ICU.
Main Outcomes and Measures
The primary outcome was VAP determined by duplicate blinded central adjudication. Secondary outcomes were other ICU-acquired infections includingClostridioides difficileinfection, diarrhea, antimicrobial use, ICU and hospital length of stay, and mortality.
Results
Among 2653 randomized patients (mean age, 59.8 years [SD], 16.5 years), 2650 (99.9%) completed the trial (mean age, 59.8 years [SD], 16.5 years; 1063 women [40.1%.] with a mean Acute Physiology and Chronic Health Evaluation II score of 22.0 (SD, 7.8) and received the study product for a median of 9 days (IQR, 5-15 days). VAP developed among 289 of 1318 patients (21.9%) receiving probiotics vs 284 of 1332 controls (21.3%; hazard ratio [HR], 1.03 (95% CI, 0.87-1.22;P = .73, absolute difference, 0.6%, 95% CI, –2.5% to 3.7%). None of the 20 prespecified secondary outcomes, including other ICU-acquired infections, diarrhea, antimicrobial use, mortality, or length of stay showed a significant difference. Fifteen patients (1.1%) receiving probiotics vs 1 (0.1%) in the control group experienced the adverse event ofL rhamnosusin a sterile site or the sole or predominant organism in a nonsterile site (odds ratio, 14.02; 95% CI, 1.79-109.58;P < .001).
Conclusions and Relevance
Among critically ill patients requiring mechanical ventilation, administration of the probioticL rhamnosusGG compared with placebo, resulted in no significant difference in the development of ventilator-associated pneumonia. These findings do not support the use ofL rhamnosusGG in critically ill patients.
