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临床试验/NCT07298889
NCT07298889
招募中
不适用

Effect of High Versus Low Positive End-Expiratory Pressure on Intubation-Free Survival in Patients With Pneumonia or ARDS Receiving Noninvasive Ventilation: A Multicenter Randomized Controlled Trial

Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 706 人开始时间: 2026年1月4日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Chongqing Medical University
入组人数
706
试验地点
1
主要终点
28-day intubation-free survival

概览

简要总结

Noninvasive ventilation is commonly employed in patients with pneumonia or acute respiratory distress syndrome (ARDS) and has been shown to reduce the need for intubation and invasive mechanical ventilation. However, the rate of noninvasive ventilation failure remains substantial, at approximately 40%. Compared with patients in whom noninvasive ventilation succeeds, those who experience noninvasive ventilation failure have a higher likelihood of mortality during their intensive care unit or hospital stay. Therefore, improving the success rate of noninvasive ventilation is clinically important. In patients with lung consolidation receiving invasive mechanical ventilation, high positive end-expiratory pressure (PEEP) can improve oxygenation. Noninvasive ventilation operates on similar physiological principles and can also deliver high PEEP via a mask interface. Nevertheless, there is limited evidence regarding the use of high PEEP during mask-delivered noninvasive ventilation. This study aimed to evaluate whether high PEEP can increase intubation-free survival in patients with pneumonia or ARDS who are treated with noninvasive ventilation.

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

入选标准

  • Age \>18 years
  • PaO2/FiO2 ≤300 mmHg or SpO2/FiO2 ≤315(SpO2 ≤97%)
  • Anticipated NIV duration \> 12 h
  • Preserved consciousness (GCS≥13)

排除标准

  • Use of NIV \> 24 h before randomization
  • Acute-on-chronic respiratory failure
  • Congestive heart failure
  • Use of NIV after extubation (within 48 hours)
  • Contraindications to NIV (e.g., anatomical malformations, recent pulmonary/esophageal surgery \[within 7 days\])
  • Pneumothorax
  • NIV intolerance
  • Refusal to participate
  • Pregnancy
  • Need for emergency intubation

研究组 & 干预措施

High PEEP group

Experimental

Patients in high PEEP group will received 10 to 15 cmH2O of PEEP during noninvasive ventilation.

干预措施: The level of PEEP during noninvasive ventilation (Procedure)

Low PEEP group

Active Comparator

Patients in low PEEP group will received 5 cmH2O of PEEP during noninvasive ventilation.

干预措施: The level of PEEP during noninvasive ventilation (Procedure)

结局指标

主要结局

28-day intubation-free survival

时间窗: from randomization to 28 days after randomization

次要结局

  • 28-day intubation rate(from randomization to 28 days after randomization)
  • the need for intubation within 28 days(from randomization to 28 days after randomization)
  • 28-day survival(from randomization to 28 days after randomization)
  • 7-category ordinal scale for clinical improvement at 28 days(from randomization to 28 days after randomization)
  • 28-day noninvasive ventilator days(from randomization to 28 days after randomization)
  • Length of ICU stay(up to 24 weeks)
  • 28-day invasive ventilator-free days(from randomization to 28 days after randomization)
  • Length of hospital stay(up to 24 weeks)
  • ICU mortality(up to 24 weeks)
  • Hospital mortality(up to 24 weeks)
  • 60-day mortality(from randomization to 60 days after randomization)

研究者

发起方
Chongqing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Duan jun

attending physician

First Affiliated Hospital of Chongqing Medical University

研究点 (1)

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