Liberation from mechanical ventilation using Extubation Advisor Decision Support (LEADS)

The LEADS pilot RCT is a part of the Extubation Advisor program of research.

Timely and safe extubation (i.e., endotracheal tube removal) in critically ill patients is vitally important as prolonged mechanical ventilation and failed attempts at extubation (i.e., reintubation<48 hrs; 15% incidence) are associated with increased morbidity, mortality, costs, intensive care unit (ICU) stays, and a risk for aerosolization of COVID-19 to health care providers. A Spontaneous Breathing Trial (SBT) is the current standard of care to assess a patient’s readiness for extubation. However, SBTs are performed in various ways and have a poor ability to predict successful extubation on their own. There is an urgent need to improve and standardize extubation decision-making in the intensive care unit.

In a prior multicenter study (WAVE study, n=721), we showed that decreased respiratory rate variability during SBTs predicted extubation failure better than other predictive indices. The Extubation Advisor (EA) tool was developed from the WAVE study and combines a clinician’s assessment of extubation readiness with predictive analytics and risk mitigation strategies for individual patients. In a single centre observational study (n=117; 2 ICUs), we demonstrated the ability to deliver EA reports to the bedside and the acceptability of this decision-support tool to respiratory therapists (RTs) and physicians (MDs).

We are now poised to start the Liberation from mechanical ventilation using EA Decision Support (LEADS) Pilot Trial, a feasibility RCT designed to inform the design of a future, large-scale randomized controlled trial that is expected to enhance the care delivered to critically ill patients, improve extubation outcomes, and inform extubation practice in our ICUs. The LEADS trial is the first trial to evaluate the use of a bedside decision support tool to assist ICU clinicians with extubation decision-making.