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临床试验/NCT05508997
NCT05508997已完成不适用

Response of Respiratory and Hemodynamic Parameters to Positive End-Expiratory Pressure Titration for Mechanically Ventilated Obese Patients: A Randomized Clinical Trial

Heidy F. Ahmed2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年12月1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
60
试验地点
2
主要终点
Respiratory parameters

研究概览

简要总结

In this study, the sixty mechanically ventilated class I obese patients were divided into two equal groups A and B. group A received RTP position + PEEP protocol, while group B underwent RTP position protocol only. The results showed that the group A protocol has positive effects on the improvement of respiratory mechanics by significant increase the arterial oxygen partial pressure (PaO2) in mmHg to fractional inspired oxygen (FiO2), (PaO2/FiO2 ratio), partial pressure of carbon dioxide (PaCO2), and static compliance (Cstat) parameters. Moreover, a significant decrease in hemodynamics of BP& MAP was measured. While the results of the group B protocol demonstrated a non-significant increase in the PaO2/FiO2 ratio, PaCO2, and Cstat. Besides, non-significant decreases in hemodynamics of blood pressure (BP) & mean arterial blood pressure (MAP) were recorded.

详细描述

Objective To investigate the effect of the positive end-expiratory pressure (PEEP) titration maneuver with Reverse Trendelenburg Position (RTP) on the respiratory and hemodynamic parameters of mechanically ventilated obese patients.

Design Randomized, control trial. Participants Thirty mechanically ventilated obese patients were randomized equally as a group A to receive Reverse Trendelenburg Position (RTP) + Positive End Expiratory Pressure (PEEP) titration, and group (B): receive Reverse Trendelenburg Position (RTP).

Intervention After post-operative bariatric surgeries, the sixty mechanically ventilated obese patients immediately receive a PEEP and RTP once before the weaning through the ventilator of the operation to evaluate the response of arterial blood gases before admission to the intensive care unit ICU room.

Outcomes The primary outcomes included the respiratory parameters (PaO2/FiO2 ratio, PaCO2, Cstat), and the secondary outcomes included the hemodynamics parameters (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP)).

研究设计

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

盲法说明

the patients were under general anesthesia didn't know which procedure they received & the outcomes assessor done by my supervisors and didn't know which result related to specific group

入排标准

年龄范围
40 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects included in this study had the following criteria:
  • Mechanically ventilated obese patients in operation room undergoing upper abdominal surgeries (bariatric) and under general anesthesia.
  • Obese patients with BMI (30-34.9).
  • Age 40-50 years old.
  • Both sexes.
  • Non-smoker.
  • No history of disease affecting the heart & lungs.

排除标准

  • Subjects with any of the following were excluded from the study:
  • Severe head injury.
  • Increase intracranial pressure and who are potentially liable to develop pathologically raised intracranial pressure.
  • Acute pulmonary edema.
  • Barotrauma/volutrauma.
  • Un-drained Pneumothorax/Hemothorax.
  • Flail chest.
  • Low blood pressure (systolic less than 80 mmHg).
  • Oxygen saturation is less than 90%.

结局指标

主要结局

Respiratory parameters

时间窗: Immediately after the procedure is done in the operating room appears on the patient's monitor & patient arterial blood gases.

The primary outcomes included the respiratory parameters partial oxygen pressure, partial carbon dioxide pressure, static compliance fractional oxygen pressure ratio

次要结局

  • Hemodynamics parameters(Immediately after the procedure is done in the operating room appears on the patient's monitor.)

研究者

发起方
Heidy F. Ahmed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Heidy F. Ahmed

Doctor of physical therapy at Al kasr Al Anini teaching hospital, Cairo, Egypt

Cairo University

研究点 (2)

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