Clinical trial NCT05483959: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Keywords: BIPAP , ARDS
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: BIPAP mode of ventilation applied to 20patients , SIMV PC mode applied to the other group
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: 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
timeFrame: Baseline
measure: Blood pressure in mm Hg of BIPAP group and SIMV PC group will be measured by the sphygmomanometer device
timeFrame: Base line
measure: 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
timeFrame: 24 hours after mechanical ventilation
Secondary outcomes:
measure: Duration of mechanical ventilation of BIPAP group
timeFrame: 6 weeks
measure: The duration of anesthesia in days
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Shymaa Sayed Salem
state: Qina
Study officials:
affiliation: Assiut University
name: Khaled H Ahmed, Professor
role: STUDY_DIRECTOR
affiliation: faculty of medicine, South Valley University
name: Alaa R Mahmoud, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: faculty of medicine, South Valley University
name: Gad S Gad, Professor
role: STUDY_CHAIR
References:
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.
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.
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.