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Not yet recruiting NCT07724392

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

No phase Interventional Spontaneous Breathing Trial in ICU

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: T piece, PSV, HFO.
Who it may be relevant to
Registry conditions: Spontaneous Breathing Trial in ICU. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

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.

Primary outcome measures

  • 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. [Time frame: 190 min]
Secondary outcome measures (8)
  • Tidal Volume [Time frame: 190 min]
  • Total Positive End-Expiratory Pressure [Time frame: 190 min]
  • Respiratory Rate [Time frame: 190 min]
  • minute ventilation [Time frame: 190 min]
  • Ratio Respiratory rate/ Tidal volume [Time frame: 190 min]
  • product pressure time [Time frame: 190 min]
  • Occlusion pressure (or P 0.1) [Time frame: 190 min]
  • Percentage of success on the weaning test (predefined criteria) [Time frame: 190 min]

Eligibility criteria

Inclusion criteria

  • Adult patient, of legal age
  • On invasive mechanical ventilation for more than 48 hours
  • With at least one criterion indicating a high risk of extubation failure:
  • Age > 65 years
  • Chronic respiratory disease
  • Chronic cardiac disease
  • Capable of undergoing a mechanical ventilation weaning test ("weaning criterion"):
  • Respiratory rate < 35 bpm
  • Adequate oxygenation:
  • SpO₂ ≥ 90% with FiO₂ ≤ 40% and PEEP ≤ 8 cm H₂O
  • Or PaO₂/FiO₂ ≥ 150 with PEEP ≤ 8 cm H₂O
  • Effective cough
  • Patient is alert (RASS score -2 to +1), without sedation
  • Hemodynamically stable or on the minimum effective dose
  • Patient has an invasive arterial pressure catheter for arterial blood sampling
  • Informed consent signed by a family member
  • Patient is enrolled in or eligible for a social security program

Exclusion criteria

  • Resuscitation-associated neuromyopathy
  • History of neuromuscular disease
  • Admission for a neurological condition
  • Subjects currently excluded from another study,
  • Persons referred to in Articles L1121-5 through L1121-8 of the CSP (corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a health or social care facility for purposes other than research, minors, and persons subject to a legal protection order or unable to give informed consent).
  • Staff members who report to the principal investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07724392 · 38RC25.0307

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗