Liberation from mechanical ventilation using Extubation Advisor Decision Support (LEADS): protocol for a multicentre...

Area of Science:

• Critical Care Medicine
• Respiratory Therapy
• Clinical Decision Support

Background:

• Successful extubation is crucial for minimizing patient exposure to invasive ventilation, reducing costs, and improving outcomes.
• Current strategies lack robust evaluation for informing extubation decisions.
• The LEADS Pilot Trial introduces a novel Extubation Advisor (EA) tool to address this gap.

Purpose of the Study:

• To assess the feasibility of conducting a larger trial for a novel extubation decision support tool.
• To evaluate key feasibility metrics including recruitment, consent, randomization, and adherence rates.
• To explore physician perceptions of the EA tool's utility and implementation costs.

Main Methods:

• A pilot randomized controlled trial involving critically ill adults invasively ventilated for ≥48 hours.
• Intervention arm: Patients receive an Extubation Advisor (EA) assessment measuring respiratory rate variability for extubation readiness.
• Control arm: Patients receive standard care; EA reports are not used.

Main Results:

• The study aims to recruit 1-2 patients/month across 10 centers.
• Target feasibility outcomes include >75% consent rate, >95% randomization, >80% intervention adherence, <10% crossovers, and >90% complete clinical outcomes.
• Physician perceptions of the EA tool's usefulness will be reported.

Conclusions:

• This pilot study is essential for determining the feasibility of a definitive trial on the Extubation Advisor.
• Successful implementation of the LEADS trial will provide critical data for optimizing extubation strategies.
• Findings will guide future research on improving patient outcomes through enhanced decision support during mechanical ventilation liberation.