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

NCT07724392 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-24

No results posted yet for this study

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).

Conditions

  • Spontaneous Breathing Trial in ICU

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.

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2027-01-31
Completion
2027-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07724392 on ClinicalTrials.gov