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临床试验/NCT04376047
NCT04376047已完成不适用

Effect of Reverse Trendelenburg Position Versus Semi-recumbent Position on Ventilation and Oxygenation Parameters in Obese Critically Ill Patients: Randomized Controlled Trial

Alexandria University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年1月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Respiratory dynamic compliance

研究概览

简要总结

The aim of this study is to assess the effect of reverse Trendelenburg position versus semi-recumbent position on ventilation and oxygenation parameters of obese critically ill patients

详细描述

Obese critically ill patients' position significantly impacts on their ventilation and oxygenation status. It is also associated with mechanical ventilation success or failure and may be a main determinant of the obese patients' outcome. Reverse Trendelenburg position is recommended for obese patients but in critical illness with mechanical ventilation little is known about its effect on respiratory therapeutic targets. This trial was conducted in four general intensive care unit of Alexandria Main University hospital in Alexandria, Egypt. One hundred and ten adult mechanically ventilated patients with body mass index ≥ 30 were randomly assigned by a computer program to either reverse Trendelenburg position group (n=55) which is the intervention group or semi-recumbent position group (n=55) which is the routine unit position. Patients were positioned in the study positions 4 times per day. Patients were maintained in the study positions for 2 hours each time. Baseline ventilation and oxygenation parameters were assessed immediately before positioning then it was reassessed every 10 minutes after positioning for 30 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

盲法说明

Computer generated randomization (www.randomizer.org) was used to randomly assign patients to one of both groups. Information of allocation was available to the principal researcher only. Patients were assigned a sequential number that was placed in an opaque, sealed envelope by the researcher. When the patients were scheduled to be positioning, the envelope was opened by the researcher who then performed the positioning. The nurses could not be blinded to the allocation because of the nature of the intervention. However, the outcome assessment of the patients was blinded.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •body mass index ≥ 30
  • •Mechanically ventilated

排除标准

  • •Acute respiratory distress syndrome

研究组 & 干预措施

Reverse Trendelenburg position group

Experimental

Obese critically ill patients who are positioned in reverse Trendelenburg position

干预措施: Reverse Trendelenburg position (Other)

Semi-recumbent position group

Active Comparator

Obese critically ill patients who are positioned in semi-recumbent position which is the routine ICU position

干预措施: Semi-recumbent position (Other)

结局指标

主要结局

Respiratory dynamic compliance

时间窗: 30 minute form positioning time

Respiratory dynamic compliance (Cdyn) in ml/cm H2O is the change in lung volume per unit change in pressure in the presence of flow. It is calculated through the equation of tidal volume/ (peak inspiratory pressure - positive end expiatory pressure). All the previous equation variables are assessed from the patient's mechanical ventilator data.

Partial pressure carbon dioxide

时间窗: 30 minute form positioning time

Partial pressure carbon dioxide (PaCO2) in mm Hg is assessed from arterial blood gases sample.

Respiratory minute volume

时间窗: 30 minute form positioning time

Respiratory minute volume (VE) in mL/min is the total volume of air that is expired over one minute. It is calculated directly by the mechanical ventilator and presented on patient's mechanical ventilator data.

Partial pressure oxygen

时间窗: 30 minute form positioning time

Partial pressure oxygen (PaO2) in mm Hg is assessed from arterial blood gases sample.

Hypoxemic index

时间窗: 30 minute form positioning time

Hypoxemic index is the ratio of partial pressure oxygen to fraction inspiratory oxygen (PaO2/FiO2).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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