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BIPAP in the Management of Acute Respiratory Distress Syndrome

Primary Purpose

Mechanical Ventilation Complication

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
BIPAP mode/SIMV PC mode
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mechanical Ventilation Complication focused on measuring BIPAP , ARDS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shymaa Sayed Salem

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BIPAP group

SIMV PC group

Arm Description

Mechanically ventilated ARDS patients on BIPAP mode of ventilation

Mechanically ventilated ARDS patients on SIMV PC mode of ventilation

Outcomes

Primary Outcome Measures

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

Duration of mechanical ventilation of BIPAP group
The duration of mechanical ventilation duration had been compared between both groups
The duration of anesthesia in days
The duration of anesthesia in days on BIPAP group willassessed between BIPAP group and SIMV PC group

Full Information

First Posted
July 25, 2022
Last Updated
July 29, 2022
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT05483959
Brief Title
BIPAP in the Management of Acute Respiratory Distress Syndrome
Official Title
Biphasic Positive Airway Pressure in the Management of Acute Respiratory Distress Syndrome: A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
July 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation Complication
Keywords
BIPAP , ARDS

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
BIPAP mode of ventilation applied to 20patients , SIMV PC mode applied to the other group
Masking
Participant
Masking Description
Mechanically ventilated ARDS patients
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIPAP group
Arm Type
Experimental
Arm Description
Mechanically ventilated ARDS patients on BIPAP mode of ventilation
Arm Title
SIMV PC group
Arm Type
Experimental
Arm Description
Mechanically ventilated ARDS patients on SIMV PC mode of ventilation
Intervention Type
Other
Intervention Name(s)
BIPAP mode/SIMV PC mode
Intervention Description
BIPAP is a mode of ventilation recently used in ARDS
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Baseline
Title
Blood pressure in mm Hg of BIPAP group and SIMV PC group will be measured by the sphygmomanometer device
Description
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
Time Frame
Base line
Title
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
Description
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
Time Frame
24 hours after mechanical ventilation
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation of BIPAP group
Description
The duration of mechanical ventilation duration had been compared between both groups
Time Frame
6 weeks
Title
The duration of anesthesia in days
Description
The duration of anesthesia in days on BIPAP group willassessed between BIPAP group and SIMV PC group
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled H Ahmed, Professor
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alaa R Mahmoud, Professor
Organizational Affiliation
faculty of medicine, South Valley University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gad S Gad, Professor
Organizational Affiliation
faculty of medicine, South Valley University
Official's Role
Study Chair
Facility Information:
Facility Name
Shymaa Sayed Salem
City
Qinā
State/Province
Qina
ZIP/Postal Code
1462506
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
22797452
Citation
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
Results Reference
background
PubMed Identifier
12205405
Citation
Hedenstierna G, Lattuada M. Gas exchange in the ventilated patient. Curr Opin Crit Care. 2002 Feb;8(1):39-44. doi: 10.1097/00075198-200202000-00007.
Results Reference
background
PubMed Identifier
8143712
Citation
Hormann C, Baum M, Putensen C, Mutz NJ, Benzer H. Biphasic positive airway pressure (BIPAP)--a new mode of ventilatory support. Eur J Anaesthesiol. 1994 Jan;11(1):37-42.
Results Reference
result

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BIPAP in the Management of Acute Respiratory Distress Syndrome

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