BIPAP in the Management of Acute Respiratory Distress Syndrome

NCT05483959 | Completed

• 1 other identifier: BIPAP IN ARDS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication

Keywords

BIPAP , ARDS

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Duration of mechanical ventilation of BIPAP group

  6 weeks

• The duration of anesthesia in days

  2 weeks

Study Arms (2)

BIPAP group

EXPERIMENTAL

Mechanically ventilated ARDS patients on BIPAP mode of ventilation

Other: BIPAP mode/SIMV PC mode

SIMV PC group

EXPERIMENTAL

Mechanically ventilated ARDS patients on SIMV PC mode of ventilation

Other: BIPAP mode/SIMV PC mode

Interventions

BIPAP mode/SIMV PC mode OTHER

BIPAP is a mode of ventilation recently used in ARDS

BIPAP group; SIMV PC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Shymaa Sayed Salem

Qina, Qena Governorate, 1462506, Egypt

Location

Related 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.

  PMID: 22797452 BACKGROUND

• 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.

  PMID: 12205405 BACKGROUND

• 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.

  PMID: 8143712 RESULT

Study Officials

• Khaled H Ahmed, Professor

  Assiut University

  STUDY DIRECTOR

• Alaa R Mahmoud, Professor

  faculty of medicine, South Valley University

  PRINCIPAL INVESTIGATOR

• Gad S Gad, Professor

  faculty of medicine, South Valley University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Mechanically ventilated ARDS patients
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: BIPAP mode of ventilation applied to 20patients , SIMV PC mode applied to the other group

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 2, 2022
• Study Start: April 20, 2019
• Primary Completion: November 30, 2021
• Study Completion: July 22, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

EG (1)