BIPAP in the Management of Acute Respiratory Distress Syndrome

NCT ID: NCT05483959

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-20

Study Completion Date

2022-07-22

Brief Summary

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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

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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.

Conditions

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Mechanical Ventilation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

BIPAP mode of ventilation applied to 20patients , SIMV PC mode applied to the other group
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Mechanically ventilated ARDS patients

Study Groups

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BIPAP group

Mechanically ventilated ARDS patients on BIPAP mode of ventilation

Group Type EXPERIMENTAL

BIPAP mode/SIMV PC mode

Intervention Type OTHER

BIPAP is a mode of ventilation recently used in ARDS

SIMV PC group

Mechanically ventilated ARDS patients on SIMV PC mode of ventilation

Group Type EXPERIMENTAL

BIPAP mode/SIMV PC mode

Intervention Type OTHER

BIPAP is a mode of ventilation recently used in ARDS

Interventions

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BIPAP mode/SIMV PC mode

BIPAP is a mode of ventilation recently used in ARDS

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Shymaa Sayed Salem

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khaled H Ahmed, Professor

Role: STUDY_DIRECTOR

Assiut University

Alaa R Mahmoud, Professor

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine, South Valley University

Gad S Gad, Professor

Role: STUDY_CHAIR

faculty of medicine, South Valley University

Locations

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Shymaa Sayed Salem

Qina, Qena Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 22797452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12205405 (View on PubMed)

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.

Reference Type RESULT
PMID: 8143712 (View on PubMed)

Other Identifiers

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BIPAP IN ARDS

Identifier Type: -

Identifier Source: org_study_id

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