此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation Versus Conventional Management in Weaning Window Patients

2026年7月11日更新者：Muhammad Ahmed Kandil、Tanta University

Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation Versus Conventional Management in Weaning Window Patients: A Randomized Controlled Trial

This study aims to determine whether Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation is superior to conventional management for patients in weaning windows.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Mechanical ventilation is an essential modality for critically ill patients with acute respiratory failure. It supports gas exchange and reduces respiratory muscle workload, but prolonged use increases the risk of lung injury, diaphragm dysfunction, and infection. Therefore, the process of ventilator weaning is crucial in optimizing patient outcomes.

Airway occlusion pressure (P0.1), the negative pressure generated 100 ms after the onset of inspiration during an occluded breath, provides a direct measurement of patient respiratory drive independent of lung mechanics. It is a strong indicator of ventilatory demand and drive-load imbalance.

Pressure Support Ventilation (PSV) is commonly used during the weaning window, but conventional titration methods rely on clinical assessment alone. These methods do not reliably identify asynchronous events such as ineffective effort, double triggering, or premature cycling, which prolong ventilation.

研究类型

介入性

注册 (估计的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Muhammad A Kandil, MSc
电话号码：00201022644722
邮箱：muhammad.kandil@med.tanta.edu.eg

学习地点

埃及
- Al Gharbia
  - Tanta、Al Gharbia、埃及、31527
    - 招聘中
    - Tanta University
    - 副研究员：
      
      Aliaa M Belal, MD
    - 副研究员：
      
      Taysser M Abdalraheem, MD
    - 副研究员：
      
      Sohair M Soliman, MD
    - 接触：
      
      Muhammad A Kandil, MSc
      
      电话号码：00201022644722
      
      邮箱：muhammad.kandil@med.tanta.edu.eg
    - 副研究员：
      
      Ghada F Elbaradey, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Mechanically ventilated adult patients ≥ 21 years.
Patients on pressure support ventilation for at least 24 hours and clinically determined to be in the weaning window (transition between assisted ventilation and spontaneous ventilation) with improving respiratory status.
Hemodynamically stable [mean arterial pressure (MAP) ≥60 mmHg].
All patients will be required to have light sedation with a Richmond Agitation-Sedation Scale (RASS) score between -1 and 0 to allow reliable assessment of respiratory drive.

Exclusion Criteria:

Patients with neuromuscular disorders affecting respiratory drive
Glasgow Coma Scale (GCS) score below 8
Cervical spinal cord injury
Receipt of neuromuscular blockers within the previous 24 hours
Morbid obesity resulting in unreliable respiratory mechanics
Pregnancy
Deep sedation defined as RASS ≤ -2
Hemodynamic instability requiring escalating vasopressor support.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：Group I (Control Group) Patients will receive a conventional pressure support ventilation protocol.	其他：Pressure support ventilation protocol Patients will receive a conventional pressure support ventilation protocol.
实验性的：Group II (Study Group) Patients will receive airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV).	其他：Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV) Patients will receive airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV).

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Ventilator-Free Days 大体时间：Day 28 after the procedure	Ventilator-Free Days (VFD) at Day 28, defined as the number of days a patient is free from mechanical ventilation within the first 28 days after randomization. VFD are calculated as 28 minus the total days on mechanical ventilation from Day 0 until successful extubation.	Day 28 after the procedure

次要结果测量

结果测量	措施说明	大体时间
Duration of Mechanical Ventilation 大体时间：Till final successful extubation (Up to 48 hours)	Duration of Mechanical Ventilation (DMV) is defined as the total days on mechanical ventilation (MV) from randomization until final successful extubation.	Till final successful extubation (Up to 48 hours)
Length of stay in the intensive care unit 大体时间：Till the discharge from intensive care unit (Up to 28 days)	The length of stay in the intensive care unit (ICU) will be recorded from ICU admission to ICU discharge.	Till the discharge from intensive care unit (Up to 28 days)
Patient-Ventilator Asynchrony Index (PVAI) 大体时间：Day 28 after the procedure	Daily analysis of a 10-minute waveform segment. "PVAI"="Asynchronous events" /"Total breaths" ×100	Day 28 after the procedure
Dexmedetomidine requirement 大体时间：Day 28 after the procedure	Total dose of dexmedetomidine administered to maintain the target sedation level of Richmond Agitation-Sedation Scale (RASS) -1 to 0 during the weaning period.	Day 28 after the procedure
Failed weaning 大体时间：48 hours after extubation	"Failed weaning" is defined as reintubation within 48 hours after extubation.	48 hours after extubation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Tanta University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月1日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2028年1月1日

研究注册日期

首次提交

2026年7月11日

首先提交符合 QC 标准的

2026年7月11日

首次发布 (实际的)

2026年7月16日

研究记录更新

最后更新发布 (实际的)

2026年7月16日

上次提交的符合 QC 标准的更新

2026年7月11日

最后验证

2026年7月1日

Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation Versus Conventional Management in Weaning Window Patients