2024-514640-81-00招募中4 期
Non-Invasive Ventilation versus High Flow Oxygenotherapy in Patients at High Risk of Extubation Failure
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana8 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2024年10月7日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 8
- 主要终点
- Acute respiratory failure within 48 hours after extubation
研究概览
简要总结
The primary objective will be the reduction of extubation failure.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •Hypercapnia (paCO2 > 45 mmHg) at the time of extubation
- •Ineffective cough
- •Abundant secretions
- •Body mass index (BMI)>30
- •Chronic obstructive pulmonary disease (COPD) or asthma as a cause of invasive mechanical ventilation
- •Cardiac failure as a cause of intubation or history of ejection fraction <= 30%
- •Acute Physiology and Chronic Health Evaluation (APACHE II) > 12 at the time of extubation
- •Time of mechanical ventilation > 7 days
- •Positive water balance
- •Difficult or prolonged weaning
- •Pneumonia (or any medical pathology over surgical) as a cause of ARF
排除标准
- •Structural neurologic disease
- •Direct extubation without performing a spontaneous breathing trial
- •Contraindication to apply NIV or high flow oxygen
- •Not intubation order
- •Life support therapy limitation
- •Tracheotomized
- •Spinal cord injury
- •Scheduled surgical intervention in the next 48 hours post-extubation
- •Re-admission
- •Transfer to another center
- •Refusal of the patient or relatives
结局指标
主要结局
Acute respiratory failure within 48 hours after extubation
Acute respiratory failure within 48 hours after extubation
次要结局
- Intubation
- Nosocomial infection
- Tracheotomy
- Organ failure
- ICU Mortality
- Hospital mortality
- 28-day mortality
- ICU length of stay
- Hospital length of stay
- Duration of mechanical ventilation
研究者
Alberto Belenguer Muncharaz / Héctor Hernández Garcés
Scientific
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
研究点 (8)
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