BIPAP in the Management of Acute Respiratory Distress Syndrome

Sponsor
South Valley University (Other)
Overall Status
Completed
CT.gov ID
NCT05483959
Collaborator
(none)
40
1
2
39.1
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: BIPAP mode/SIMV PC mode
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
BIPAP mode of ventilation applied to 20patients , SIMV PC mode applied to the other groupBIPAP mode of ventilation applied to 20patients , SIMV PC mode applied to the other group
Masking:
Single (Participant)
Masking Description:
Mechanically ventilated ARDS patients
Primary Purpose:
Other
Official Title:
Biphasic Positive Airway Pressure in the Management of Acute Respiratory Distress Syndrome: A Comparative Study
Actual Study Start Date :
Apr 20, 2019
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Jul 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: BIPAP group

Mechanically ventilated ARDS patients on BIPAP mode of ventilation

Other: BIPAP mode/SIMV PC mode
BIPAP is a mode of ventilation recently used in ARDS

Experimental: SIMV PC group

Mechanically ventilated ARDS patients on SIMV PC mode of ventilation

Other: BIPAP mode/SIMV PC mode
BIPAP is a mode of ventilation recently used in ARDS

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

Secondary Outcome Measures

  1. Duration of mechanical ventilation of BIPAP group [6 weeks]

    The duration of mechanical ventilation duration had been compared between both groups

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shymaa Sayed Salem Qinā Qina Egypt 1462506

Sponsors and Collaborators

  • South Valley University

Investigators

  • Study Director: Khaled H Ahmed, Professor, Assiut University
  • Principal Investigator: Alaa R Mahmoud, Professor, faculty of medicine, South Valley University
  • Study Chair: Gad S Gad, Professor, faculty of medicine, South Valley University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shymaa Sayed Salem, doctor, South Valley University
ClinicalTrials.gov Identifier:
NCT05483959
Other Study ID Numbers:
  • BIPAP IN ARDS
First Posted:
Aug 2, 2022
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shymaa Sayed Salem, doctor, South Valley University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022