About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient, of legal age
On invasive mechanical ventilation for more than 48 hours
Age > 65 years
Chronic respiratory disease
Disqualifiers
Resuscitation-associated neuromyopathy
History of neuromuscular disease
Admission for a neurological condition
Subjects currently excluded from another study,
Trial design
Crossover
Treatments tested in this trial
T piece
DeviceThe endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
PSV
DeviceThe endotracheal tube will be connected to the pneumotachograph. The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
HFO
DeviceThe endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher \& Paykel, Optiflow+®) will be connected to the pneumotachograph. The OHD flow rate will be set to 50 L/min. A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Respiratory work during the weaning test, defined as the energy expended to inhale and exhale a respiratory gas, measured in joules per liter per minute.
Secondary outcomes
Tidal Volume
Total Positive End-Expiratory Pressure
Respiratory Rate
minute ventilation
Other outcomes
Percentage of patients extubated following the series of weaning trials
Percentage of reintubations within 48 hours after extubation
Locations
Sponsors and contacts
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