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临床试验/NCT04442815
NCT04442815已完成不适用

Analysis of Patient Ventilator Asynchrony Using Electrical Impedance Tomography (EIT) in Patients With Acute Respiratory Failure

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Patient ventilator asynchrony

研究概览

简要总结

Patient-ventilator asynchrony is an important clinical issue in mechanically ventilated patients. For patients with moderate to severe acute respiratory distress syndrome (ARDS), various types of patient ventilator asynchrony may lead to injury of the lung. For example, double cycling may lead to high tidal volume and pendelluft may result in transient overstretch of dependent lung region. In this project, the investigators will record and analyze various types of patient-ventilator asynchrony in ARDS patients and analyze the regional distribution of lung gas and determined their harmful effect via concomitant recording of EIT and transpulmonary pressure. The results may influence our ventilator management of ARDS patients.

详细描述

Patients and Methods:

Admitted ventilated patients who are greater than 18 years old and fulfilled the Berlin's diagnostic criteria of moderate to severe ARDS will be selected to enter our study. The exclusion criteria include (1) patients with metallic materials in the body (including wire, pin or implanted electrical devices etc.); (2) patients with cutaneous diseases which prohibited the application of electrode leads to attached the body; (3) severe chronic obstructive pulmonary diseases; (4) hemodynamically unstable; (5) proved barotrauma (including pneumothorax or pneumomediastinum etc.); (6) pregnancy; (7) diseases characterized with increased intracranial pressure; (8) patients or family who refused the informed consent. All patients who fulfilled the diagnosis of ARDS will receive standard care of low tidal volume ventilator therapy. The tidal volume 6 ml/Kg will be used. The investigators expect to enroll at least 20 analyzable cases. Sedation and paralysis are usually used in moderate to severe ARDS patients and daily interruption of sedation and paralysis is a standard practice. The investigators will perform recording during daily interruption of sedation and paralysis, up to 60 minutes period will be recorded during the interruption period. Recording will be done at least once for registered case and could be repeated in case of unsatisfactory signals.

Instrumentation In all patients, air flow will be measured using a pneumotachograph (Hamilton AG, or Hans Rudolf) connected to a differential pressure transducer (MP 45, Validyne Corp., Northridge, CA). The flow sensor will be placed between the endotracheal tube and the Y-piece of the ventilator. Tidal volume will be obtained by integrating the flow signal. Airway pressure and esophageal pressure will be measured using differential pressure transducers (P300D, Validyne Corp., Northridge, CA.). An appropriate esophageal pressure signal will be confirmed according to the standard guideline[27]. All signals are sampled and digitalized at 200 Hz and data are stored in a data acquisition system (MP150, Acqknowledgement, Biopac, Goleta, CA).

Measurements:

Electrical impedance tomography:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Clinical diagnosis of moderate to severe ARDS

排除标准

  • Severe chronic obstructive pulmonary diseases
  • Proved barotrauma (including pneumothorax or pneumomediastinum etc.);
  • Pregnancy
  • Diseases characterized with increased intracranial pressure
  • Patients or family who refused the informed consent.

结局指标

主要结局

Patient ventilator asynchrony

时间窗: up to 1 hour following interruption of muscle relaxant

Various types of patient ventilator asynchrony

Regional ventilation distribution by EIT

时间窗: up to 1 hour following interruption of muscle relaxant

Regional ventilation distribution by EIT in various types of patient ventilator asynchrony

次要结局

  • hospitalization day and final outcome(up to 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang-Wen Chen

Associate professor and attending physician

National Cheng-Kung University Hospital

研究点 (1)

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