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

Обзор

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).

Вмешательства

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

Первичные конечные точки

• 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. [Срок оценки: 190 min]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07724392 · 38RC25.0307

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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