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CompletedNCT05483959Updated Aug 2, 2022

BIPAP in the Management of Acute Respiratory Distress Syndrome

An interventional study of BIPAP mode/SIMV PC mode in Mechanical Ventilation Complication, sponsored by South Valley University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-02.

Sponsored by South Valley University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Apr 2019, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mechanical Ventilation Complication

Keywords

  • BIPAP , ARDS
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

South Valley University is the lead sponsor of 147 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    BIPAP group

    Mechanically ventilated ARDS patients on BIPAP mode of ventilation

    Other: BIPAP mode/SIMV PC mode

  • Experimental
    SIMV PC group

    Mechanically ventilated ARDS patients on SIMV PC mode of ventilation

    Other: BIPAP mode/SIMV PC mode

Interventions

  • OtherBIPAP mode/SIMV PC mode

    BIPAP is a mode of ventilation recently used in ARDS

06

What researchers measure

Primary outcomes

  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

    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

  2. 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

    Time frame: Base line

  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

    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 outcomes

  1. Duration of mechanical ventilation of BIPAP group

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

    Time frame: 6 weeks

  2. The duration of anesthesia in days

    The duration of anesthesia in days on BIPAP group willassessed between BIPAP group and SIMV PC group

    Time frame: 2 weeks

07

Study locations

1 site
  • Shymaa Sayed Salem
    Qinā, Qina 1462506, Egypt
08

References and documents

Publications

  • 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. PubMed 22797452 ↗
  • 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. PubMed 12205405 ↗
  • 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. PubMed 8143712 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05483959
Lead sponsor
South Valley University
Responsible party
Shymaa Sayed Salem (doctor, South Valley University) — Principal investigator
First posted
Aug 2, 2022
Start date
Apr 20, 2019
Primary completion
Nov 30, 2021
Completion
Jul 22, 2022
Last update
Aug 2, 2022

Study contacts

Khaled H Ahmed, Professor
study director · Assiut University
Alaa R Mahmoud, Professor
principal investigator · faculty of medicine, South Valley University
Gad S Gad, Professor
study chair · faculty of medicine, South Valley University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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