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NCT Number: NCT05483959

BIPAP in the Management of Acute Respiratory Distress Syndrome

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.

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Key information

Conditions

Mechanical Ventilation Complication

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shymaa Sayed Salem

Qina, Qena Governorate, 1462506, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIPAP mode/SIMV PC mode

Other

BIPAP is a mode of ventilation recently used in ARDS

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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Duration of mechanical ventilation of BIPAP group

    Time frame: 6 weeks

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

  2. The duration of anesthesia in days

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Biphasic Positive Airway Pressure in the Management of Acute Respiratory Distress Syndrome: A Comparative Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 2, 2022
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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