Early Postoperative Extubation in Hypoxemic ICU Patients: a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 152
- 试验地点
- 22
- 主要终点
- time to ventilatory weaning
研究概览
简要总结
The objective of this clinical trial is to assess whether early extubation of patients with hypoxemia during the spontaneous breathing trial (SBT) shortens the duration of ventilatory support. The trial will also evaluate the safety of this approach. The key research questions include:
Does early extubation of hypoxemic patients reduce the total duration of ventilatory support (both invasive and non-invasive) by 36 hours? Does early extubation of hypoxemic patients increase the number of ventilator-free days by day 28? Can the safety of early extubation in hypoxemic patients be ensured by confirming no significant differences in rates of reintubation, tracheostomy, or mortality? The trial will compare ventilatory outcomes between two groups: hypoxemic patients who undergo early extubation (hypoxemic extubation group) and those who remain on invasive ventilation until hypoxemia resolves (conventional extubation group).
详细描述
International guidelines recommend extubating patients after correction of hypoxemia, meaning if the SpO2 measured during the spontaneous breathing trial is above 92%. However, there is strong rationale for modifying this practice to extubate patients earlier, particularly those presenting with hypoxemia after major surgery, by using alternating non-invasive ventilation (NIV) and high-flow oxygen therapy:
Several studies have found no link between patient oxygenation and extubation success, where outcomes for hypoxemic and non-hypoxemic patients are similar. Isolated hypoxemia thus does not appear to be a predictor of reintubation.
Hypoxemia is very common following major surgery, primarily due to shunts caused by atelectasis. Treatment for these atelectasis includes airway pressurization, bronchial secretion drainage, mobilization, and reducing factors that lead to diaphragmatic dysfunction.
In patients on invasive mechanical ventilation, secretion drainage is impaired, and mobilization to a seated position is more challenging. It has also been shown that diaphragmatic dysfunction occurs with prolonged ventilation. Hypoxemia can therefore be sustained by invasive ventilation, increasing the risk of therapeutic escalation.
Current guidelines do not account for the widespread use of non-invasive assistance techniques (such as high-flow oxygen therapy and non-invasive ventilation) that are now routinely employed in intensive care. These techniques allow for adequate oxygenation with high patient comfort and good tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Francophone patient affiliated to a health insurance plan;
- •Patient having granted free, informed and written consent to participate in the study;
- •Patient with hypoxemia defined as SpO2 ≤ 90% under 6 L/min or FiO2 40% during spontaneous breathing trial.
排除标准
- •Presence of hypercapnia at the end of SBT (PaCO2 above 50 mmHg);
- •Presence of severe hypoxemia during SBT defined by SpO2 below 86% under 9 L/min or FiO2 = 50%;
- •Presence of poor clinical tolerance of SBT defined by polypnoea above 30/min, agitation, sweating, hypertension (PAS above 180 mmHg), tachycardia (HR above 140 bpm) or arrhythmia;
- •Presence of an ineffective cough or major bronchial congestion;
- •Patient already included in a type 1 interventional research protocol (RIPH1), modifying the procedure for ventilatory weaning and/or ventilatory support after extubation;
- •Anatomical factors precluding the use of NIV or high-flow oxygen therapy, notably facial or cervico-facial malformations;
- •Tracheostomized patient;
- •History of obstructive ventilatory disorders with indication for NIV post-extubation, chronic obstructive pulmonary disease (COPD) GOLD score III/IV;
- •History of obstructive sleep apnea syndrome with equipment;
- •cardiogenic pulmonary edema;
- •Patient on extracorporeal membrane oxygenation (ECMO) at the time of inclusion;
- •Patient under guardianship or curatorship;
- •Minor patients;
- •Patient deprived of liberty or under court protection;
- •Pregnant or breast-feeding women;
- •Patient in therapeutic limitation with decision not to re-intubate.
结局指标
主要结局
time to ventilatory weaning
时间窗: from date of randomisation until the date of cessation of non invasive ventilation or death from any cause, assessed up to 90 days after randomization
Time in hours from randomization to discontinuation of ventilatory support (invasive and non-invasive).
次要结局
- reintubation rate(up to day 90 after randomisation)
- death(at 28 and 90 days after randomisation)
- neuromyopathie score(day 7of randomisation/day of weaning from non-invasive ventilation)
- non invasive ventilation duration(from date of extubation until the date of cessation of non invasive ventilation strategy or date of reintubation assessed up to 90 days)
- ventilatory support duration between randomization and day 28(from randomisation to day 28)
- invasive ventilation duration(from date of randomisation until the date of cessation of invasive ventilation or death from any cause whichever came first assessed up to 90 days after randomization)
- Rate of ventilator-associated pneumonia.(up to day 90 after randomisation)
- Rate of pneumonia not acquired under invasive mechanical ventilation(up to 90 days after randomisation)
- time to mobilisation(from date of randomisation until the date of the first chair mobilization or death from any cause whichever came first , assessed up to 90 days after randomization)
- length of stay in ICU(from date of entrance until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization)
- time to ambulation(from date of randomisation until the date of the first ambulation or death from any cause whichever came first , assessed up to 90 days after randomization)
- length of stay in ICU after randomisation(from randomisation until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization)
- length of stay in hospital after randomisation(from date of randomisation until the date of hospital discharge or death from any cause whichever came first assessed up to 52 weeks after randomization)
- length of stay in hospital(from date of admission until the date of hospital discharge or death from any cause whichever came first assessed up to 52 weeks after randomization)