Using Extubation Advisor to Support Safe Breathing Tube Removal in Critically Ill Adults on Mechanical Ventilation The LEADS Pilot Trial

What this Trial Is About

Researchers are studying critically ill adult patients who have been on invasive mechanical ventilation for more than 48 hours and are ready to undergo a Spontaneous Breathing Trial SBT to assess readiness for extubation. The study aims to improve and standardize decision-making for extubation in intensive care units by evaluating the Extubation Advisor EA, a bedside decision support tool that combines clinician assessments with predictive analytics to better predict extubation success and failure. This pilot trial will assess the feasibility of using the EA tool and inform a future larger randomized controlled trial to enhance extubation care and outcomes. In this randomized, single-blind trial, patients in the intervention group undergo an EA assessment during their SBTs. The device records waveform data and patient information, then generates a report that helps respiratory therapists and physicians decide whether to proceed with extubation. Patients in the control group receive standard care, with SBTs directed by clinicians without EA assessments or reports. The trial will assess recruitment feasibility, adherence to the protocol, and resource use over about 12 months. Participants will be monitored with assessments including the generation and delivery of EA reports and collection of clinical outcomes until hospital discharge. Researchers will evaluate the trials success based on recruitment rates, consent and randomization rates, adherence to intervention protocols, crossover occurrences, and completeness of clinical data. They will also assess the usefulness of the EA reports and measure institutional costs and time needed to implement the device. The study duration per participant varies according to clinical care and hospital stay.

Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support