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临床试验/NCT04089111
NCT04089111尚未招募不适用

Does Automatically Generated Tidal Volumes With Closed-loop Ventilation Leads to Safe Transpulmonary Pressures in Intubated Chronic Obstructive Pulmonary Disease Patients?

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
2
主要终点
Transpulmonary inspiratory pressure (Ptinsp)

研究概览

简要总结

This study evaluates the safety and efficacy of high tidal volumes generated by "Adapted Support Ventilation (ASV) mode' in mechanically ventilated severe COPD patients. Every patient will be ventilated consecutively with ASV and Volume Control (VC) modes at 2 different levels of minute volume in 2 sets. ASV mode is expected to be safe measured by adequate inspiratory transpulmonary pressures and expected to be as effective as VC mode with lower intrinsic positive end expiratory pressure (iPEEP) levels.

详细描述

Acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) may require mechanical ventilation. Various mechanical ventilation strategies and modes can be used to manage respiratory insufficiency in such patients. High tidal volumes required for mechanical ventilation of patients with obstructive pathologies is a well-known fact. Adapted Support Ventilation (ASV) is an intelligent closed-loop mechanical ventilation mode which automatically adjusts ventilation to lung mechanics. Led by measured lung mechanics, ASV mode often generates higher than usual tidal volumes during mechanical ventilation of COPD patients, particularly if the minute volume (MV) target is high. Thus, the effects of high tidal volumes on inspiratory transpulmonary pressure (Ptp), and whether Ptp stays within safe limits during ASV mode is of great interest.

Patients with acute exacerbation of COPD who required mechanical ventilation will be enrolled in the first 24 hours of admission to the intensive care unit. All patients will be deeply sedated. An esophageal balloon catheter will be inserted in order to measure transpulmonary pressure. 100 % minute volume target will be calculated in advance as 100 ml per ideal body weight.

Patients will be ventilated with two different MV targets in two sets. 'Adapted support ventilation' and 'volume control (VC)' modes will be used consecutively within each set. While the target minute volume will be 100 % in the first set, the volume target in the second set will be tuned to decrease patients PaCO2 below 45 mmHg. The sequence of ventilation mode will be randomized within each set. Ventilation periods will be 30 minutes with 15 minutes washout period in between. İf Ptp increase above 20 cmH20 at any ventilation mode, the tidal volume will be decreased.

ASV mode is expected to be safe, assessed by adequate inspiratory transpulmonary pressures, and expected to be as effective as VC mode with lower intrinsic positive end expiratory pressure (iPEEP) levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Patients will not be aware of the procedure or ventilation modes that will be performed. Outcomes will be analyzed by an independent statistician.

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

  • Acute exacerbation of Chronic Obstructive Lung Disease
  • Being intubated for less than 24 hours
  • Not being planned to be extubated in 24 hours
  • Expiratory time constant (RCexp) more than > 2.0 s

排除标准

  • Restrictive lung pathologies
  • Impaired hemodynamic status
  • Esophageal pathologies
  • Bronchopleural fistula

结局指标

主要结局

Transpulmonary inspiratory pressure (Ptinsp)

时间窗: 30'th minute of each intervention arm

Ptpinsp will be measured with an inspiratory pause maneuver.

次要结局

  • Intrinsic Positive End Expiratory Pressure (PEEPi)(30'th minute of each intervention arm)

研究者

发起方
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cenk Kirakli, M.D.

Associate Professor Cenk Kirakli. M.D.

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

研究点 (2)

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