Effect of High-Flow Humidified Oxygen on Ventilatory Work During the Spontaneous Breathing Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- 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.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 190 min
次要结局
- Ratio Respiratory rate/ Tidal volume(190 min)
- product pressure time(190 min)
- Occlusion pressure (or P 0.1)(190 min)
- Percentage of success on the weaning test (predefined criteria)(190 min)
- Respiratory Rate(190 min)
- minute ventilation(190 min)
- Tidal Volume(190 min)
- Total Positive End-Expiratory Pressure(190 min)