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NOT YET RECRUITING
NCT07724392
NA

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

Sponsor: University Hospital, Grenoble

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2027-01

Completion Date

2027-01

Last Updated

2026-07-24

Healthy Volunteers

No

Interventions

DEVICE

T piece

The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery

DEVICE

PSV

The 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.

DEVICE

HFO

The 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.