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临床试验/NCT05483959
NCT05483959已完成不适用

Biphasic Positive Airway Pressure in the Management of Acute Respiratory Distress Syndrome: A Comparative Study

South Valley University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年4月20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
40
试验地点
2
主要终点
Oxygen saturation of the participants will be measured from the arterial blood gases taken from the patient and according to the range of oxygen saturation from 90 to 98% will be compared

研究概览

简要总结

Evaluation of biphasic positive airway pressure as a new mode of ventilation in management of acute respiratory failure constituted in ARDS as a category of hypoxaemic respiratory failure in comparison to conventional ventilation.

详细描述

Biphasic positive airway pressure (BIPAP) is a mode of mechanical ventilation that allow unrestricted spontaneous breathing independent of ventilator cycling, using an active expiratory valve. BIPAP mode is pressure-limited and time-cycled, Ventilation occurs via the time-cycled switching between two set pressure levels. In the absence of spontaneous breathing, this mode resemble conventional pressure controlled ventilation.

A proposed advantage of BIPAP compared to conventional pressure-controlled ventilation is the improved distribution of gas to dependent lung regions as the result of spontaneous breathing enabled during the inspiratory and expiratory time cycles, so prevents atelectasis and promotes alveolar recruitment resulting in an improved ventilation-perfusion matching.

ARDS is an acute diffuse, inflammatory lung injury, leading to increased pulmonary vascular permeability, increased lung weight, and loss of aerated lung tissue with hypoxemia and bilateral radiographic opacities, associated with increased venous admixture, increased physiological dead space and decreased lung compliance.

In patients with ARDS, BIPAP with spontaneous breathing contributes to improved pulmonary gas exchange, systemic blood flow and oxygen supply to the tissue. This is reflected by clinical improvement in the patient's condition, which is associated with significantly fewer days on ventilatory support, earlier extubation and a shorter stay in the intensive care unit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

盲法说明

Mechanically ventilated ARDS patients

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All intubated Adult ARDS patients
  • ARDS is diagnosed according to berlin criteria.

排除标准

  • Age < 18 years.
  • Cardiac or respiratory arrest on admission.
  • Morbid obesity with BMI >
  • Acute exacerbation of IPF.
  • Cerebrovascular or neuro muscular disorder.
  • Diabetic ketoacidosis.
  • Hepatic or renal disease. 8.Cardiac disease.

结局指标

主要结局

Oxygen saturation of the participants will be measured from the arterial blood gases taken from the patient and according to the range of oxygen saturation from 90 to 98% will be compared

时间窗: Baseline

Base line oxygen saturation of BIPAP group and SIMV PC group patients will be taken from the arterial blood gases and recorded from the range of oxygen saturation from 90 to 98% and will be compared between both groups

Lung mechanics including the tidal volume by ml per kg ideal body weight of BIPAP and SIMV PC groups will be taken from the ventilators and recorded

时间窗: 24 hours after mechanical ventilation

Lung mechanics including the tidal volume by ml per kg ideal body weight of BIPAP and SIMV PC groups will be taken from the ventilators and compared between both groups according to the range of tidal volume from 4 to 8 ml per kg ideal body weight

Blood pressure in mm Hg of BIPAP group and SIMV PC group will be measured by the sphygmomanometer device

时间窗: Base line

Blood pressure in mm Hg of BIPAP group and SIMV PC group will be measured by the sphygmomanometer device and will be compared between both groups according to the normal range of systolic blood pressure from 90mmHg to 130mmHg and diastolic blood pressure from the range of 60 mmHg to 90 mmHg

次要结局

  • Duration of mechanical ventilation of BIPAP group(6 weeks)
  • The duration of anesthesia in days(2 weeks)

研究者

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

Shymaa Sayed Salem

doctor

South Valley University

研究点 (2)

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