BIPAP in the Management of Acute Respiratory Distress Syndrome

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05483959
• Other study ID #: BIPAP IN ARDS
• Status: Completed
• Phase: N/A
• Start date: April 20, 2019
• Est. completion date: July 22, 2022

Study information

• Verified date: July 2022
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 22, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Mechanical Ventilation Complication
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
Egypt	Shymaa Sayed Salem	Qina	Qina

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

Hedenstierna G, Lattuada M. Gas exchange in the ventilated patient. Curr Opin Crit Care. 2002 Feb;8(1):39-44. Review. — View Citation

Hörmann 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	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	Base line
Primary	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	24 hours after mechanical ventilation
Secondary	Duration of mechanical ventilation of BIPAP group	The duration of mechanical ventilation duration had been compared between both groups	6 weeks
Secondary	The duration of anesthesia in days	The duration of anesthesia in days on BIPAP group willassessed between BIPAP group and SIMV PC group	2 weeks