A Randomized Controlled Trial of Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 9
- 主要终点
- Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation
研究概览
简要总结
Around 20% of the obese patients with higher body mass index (BMI) who are taken off the breathing tube and breathing machine (ventilator) end up needing it back to support breathing. The re-application of breathing tube is associated with poor outcomes, including high risk of pneumonia, longer hospital stays, and death. The purpose of this study is to assess if prophylactic use of noninvasive breathing support after removing the breathing tube lowers the chance of needing the breathing tube again.
详细描述
Patients with obesity are at risk of developing respiratory failure due to reduced lung volumes and chest wall compliance. Obesity is one of the easily identifiable, contributing factors of extubation failure that often leads to prolonged mechanical ventilation use and ICU stay. The early application of noninvasive respiratory support, especially NIV, has been shown to reduce reintubation rates in obese patients in a small, non-randomized study. However, prolonged use of NIV is often associated with decreased patient compliance and increased incidence of skin breakdown. HFNC is a noninvasive strategy that is comfortable, uses a nasal cannula and provides a high flow rate to meet the patient's inspiratory flow demand and thereby reduce work of breathing.
The purpose of this RCT will be to determine the effects of using NIV alternating with HFNC for reducing the treatment failure rate compared with HFNC alone in extubated patients with severe obesity. We hypothesize that early, prophylactic use of NIV alternating with HFNC will decrease the risk of respiratory failure (treatment failure) in severely obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adult, age ≥ 18 years old
- •Receiving invasive mechanical ventilation for ≥24 hours
- •BMI ≥40 kg/m2
- •Undergoing planned extubation per treating team
- •Arterial pH ≥7.35 or venous pH ≥ 7.31 within 30 mins of spontaneous breathing trial (SBT)
排除标准
- •Use of extra-corporeal membrane oxygenation
- •Chronic tracheostomy in place
- •Unplanned or accidental extubation
- •Terminal/compassionate extubation
- •Contraindication to NIV use
- •Intubated because of an acute exacerbation of COPD
- •Underlying neuromuscular disease
- •No reintubation requested by patient/family
- •Documented/known history of chronic hypercapnic respiratory failure on home NIV (including bilevel PAP).
- •Enrolled in any other outcome study
- •Treating clinician feels that HFNC or NIV are either mandatory or contraindicated for a given patient
研究组 & 干预措施
Control Group (HFNC alone)
Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation
干预措施: High flow nasal cannula (Device)
Intervention Group (NIV with HFNC)
Patients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation
干预措施: Noninvasive ventilation alternating with high flow nasal cannula (Device)
结局指标
主要结局
Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation
时间窗: 72 hours
Rescue respiratory support is defined as reintubation, use of rescue NIV or HFNC use
次要结局
- Reintubation rate(7 days)
研究者
Ramandeep Kaur
Principal Investigator
Rush University Medical Center