Clinical Trial

Effect of High-Flow Humidified Oxygen on Ventilatory Work During the Spontaneous Breathing Trial

Study acronym: OTRAVAIL
Not Yet Recruiting
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Summary
Weaning from mechanical ventilation (MV) accounts for a significant portion of the total MV duration, and failure to extubate or delayed extubation increases complications (particularly Ventilator-Associated Pneumonia (VAP)) and mortality. Standard tests (T-piece, Spontaneous Ventilation with Inspiratory Assistance (SV-IA)) have not demonstrated clear superiority, and the T-piece is still widely used despite its limitations. High-flow oxygen (HFO) may reduce ventilatory work and facilitate secretion clearance; however, there is a lack of physiological data in humans with an endotracheal tube in place. This study aims to address this gap prior to a subsequent clinical evaluation. An experimental, prospective, single-center, 3-period crossover study with randomized sequence order and single-blind design (primary endpoint assessment and statistical analysis were conducted in a blinded manner).
Trial Details
NCT Number NCT07724392
Lead Sponsor University Hospital, Grenoble
Conditions Spontaneous Breathing Trial in ICU
Enrollment 30 participants
Start Date 2027-01
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-24