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临床试验/NCT04475068
NCT04475068已完成不适用

Feasibility and Physiological Effects of a Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection

Hospital Nacional Edgardo Rebagliati Martins1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Effects of a postural recruitment maneuver in lung aeration

研究概览

简要总结

The purpose of this study is to evaluate if a postural recruitment maneuver (PRM) improves the aeration and distribution of lung ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 infection; without the need to reach high airway pressures as in the standard lung recruitment maneuver and / or place the patient in prone position. This strategy could be particularly useful in the context of a major health emergency in centers with limited resources.

详细描述

The PRM is based on the known effect of gravity on transpulmonary pressure (PL). Two principles explain its mechanism of action: 1) the first indicates that atelectasis and poorly ventilated areas of the lung can improve their aeration by putting the lung in the highest position. Opposite lateral decubitus causes that upper lung to have a higher PL and allow a recruiting effect at moderate airway pressures. 2) The second principle is based on Laplace's Law and postulates that once the upper lung is recruited, it remains without lung collapse if a sufficient level of positive end-expiratory pressure (PEEP) is applied. Based on these two precepts, PRM consists of sequentially moving the patient from the supine to the left lateral decubitus to recover the aeration of the right lung. After that, the patient is placed in the right lateral position to recruit the left lung; keeping the right lung without collapse by continuous use of PEEP. Finally, the patient returns to the supine position looking for an improvement in the distribution of ventilation and global pulmonary aeration, with a subsequent improvement in gas exchange and pulmonary mechanics.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Patients > 18 years of age
  • Patients with moderate-to-severe ARDS as per the Berlin definition
  • Infection due to COVID-19
  • Body mass index (BMI) ≤ 35 kg /m^2.

排除标准

  • Contraindication for EIT monitoring
  • Unstable spine or pelvic fractures
  • Pacemaker, automatic implantable cardioverter defibrillator
  • Skin lesions between the 4th and 5th ribs where the EIT belt is worn
  • Pregnancy
  • Major hemodynamic instability::
  • Mean arterial pressure lower than 60 mm Hg despite adequate fluid resuscitation and use of vasopressors.
  • FC> 120 or <60 per minute
  • Presence of uncontrolled arrhythmias.
  • More than 1 week of mechanical ventilation
  • Failure of more than 2 extrapulmonary organs.

结局指标

主要结局

Effects of a postural recruitment maneuver in lung aeration

时间窗: Through study completion (up to 24 hours)

Lung aeration measured by ultrasound reaeration score, ranges from 0 (all regions are well aerated) to 36 (all regions are consolidated).

Effects of a postural recruitment maneuver in distribution of ventilation

时间窗: Through study completion (up to 24 hours)

Distribution of ventilation measured by EIT (distribution and changes in the impedance in AU, arbitray units)

Effects of a postural recruitment maneuver in gas exchange

时间窗: Through study completion (up to 24 hours)

Gas exchange measured by blood gas analysis (PaO2, PaCO2, in mmHg) and capnography (end-tidal CO2, in mmHg)

Effects of a postural recruitment maneuver in respiratory mechanics

时间窗: Through study completion (up to 24 hours)

Respiratory mechanics measured by esophageal balloon (esophageal pressure, transpulmonary pressure, in cmH2O)

Effects of a postural recruitment maneuver in hemodynamic

时间窗: Through study completion (up to 24 hours)

Hemodynamic data measured by invasive arterial monitoring (mean arterial pressure, in mmHg)

次要结局

  • Feasibility of a postural recruitment maneuver(Through study completion (up to 24 hours))

研究者

发起方
Hospital Nacional Edgardo Rebagliati Martins
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rollin Roldán

Principal investigator

Hospital Nacional Edgardo Rebagliati Martins

研究点 (1)

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