BIPAP in the Management of Acute Respiratory Distress Syndrome

Not Applicable

Completed

• Conditions: Mechanical Ventilation Complication
• Interventions: Other: BIPAP mode/SIMV PC mode

• Registration Number: NCT05483959
• Lead Sponsor: South Valley University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-04-20
• Primary Completion: 2021-11-30
• Status Verified: 2022-07
• Study Completion: 2022-07-22
• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-29
• Last Update Submitted: 2022-07-29
• Study First Posted: 2022-08-02
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• Age < 18 years.
• Cardiac or respiratory arrest on admission.
• Morbid obesity with BMI > 40.
• Acute exacerbation of IPF.
• Cerebrovascular or neuro muscular disorder. 6. Diabetic ketoacidosis. 7. Hepatic or renal disease. 8.Cardiac disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SIMV PC group	BIPAP mode/SIMV PC mode	Mechanically ventilated ARDS patients on SIMV PC mode of ventilation
BIPAP group	BIPAP mode/SIMV PC mode	Mechanically ventilated ARDS patients on BIPAP mode of ventilation

Primary Outcome Measures

Name	Time	Method
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	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	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	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

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation of BIPAP group	6 weeks	The duration of mechanical ventilation duration had been compared between both groups
The duration of anesthesia in days	2 weeks	The duration of anesthesia in days on BIPAP group willassessed between BIPAP group and SIMV PC group

Trial Locations

Locations (1)

Shymaa Sayed Salem; 🇪🇬 Qinā, Qina, Egypt