To compare the effects of two modes of ventilation (bi-level positive airway pressure ventilation and pressure regulated volume control ventilation mode) on surgical patients admitted in ICU requiring ventilatory support.

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical, (2) ICD-10 Condition: K631||Perforation of intestine (nontraumatic),

• Registration Number: CTRI/2023/02/049658
• Lead Sponsor: Director Principal Government Medical College and Hospital

Brief Summary

Mechanical ventilation in critical care is to deliver higher concentrations of oxygen into the lungs and elimination of carbon dioxide and hence curtailing the energy expenditure of patient efforts on breathing. There are several ventilation modes available on mechanical ventilators, each with advantages and disadvantages of their own. Bi-level positive airway pressure ventilation (BIPAP) is a biphasic mode of ventilation which allows spontaneous breathing to promote lung recruitment of poorly ventilated and collapsed alveoli. Biphasic positive airway pressure (BIPAP) mode of ventilation has unique characteristics, limiting the possible lung injury and assist in automatic weaning of patients from ventilator support. Previous studies done in patients having chronic obstructive lung disease (COPD), acute respiratory distress syndrome (ARDS) and in post-cardiac surgery requiring mechanical ventilation, have shown encouraging results, when kept on BIPAP ventilator mode. The results stimulated us to conduct the proposed randomized prospective study, comparing BIPAP and PRVC mode of ventilation, in post-exploratory laparotomy patients, requiring mechanical ventilation due to acute respiratory failure.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-15
• Last Update Posted: 2023-09-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 1.Patients on invasive mechanical ventilation and admitted in ICU following exploratory laparotomy due to ARF for less than 24 hours, 2.Age group 18-60 years. 3.Stable hemodynamic parameters (Mean Arterial Pressure between 70 mm Hg.
• 100 mm Hg, Heart Rate between 60.
• 100/minute, SPO2.
• 90%) 4.Richmond Agitation–Sedation Scale (RASS)between 0 and -2.

Exclusion Criteria

• 1.Refusal of informed consent 2.Pregnant women 3.Morbidly obese patients (BMI>35) 4.Patients diagnosed with ARDS (Mild, Moderate or Severe) according to Berlin’s definition.
• 5.Patients with severe or chronic heart, lung, hepatic or renal disease 6.Patients with severe neuromuscular disorders 7.Patients on vasopressors, cardiac depressants or neuromuscular blockers 8.Patients with traumatic brain injury 9.Patients with blunt or traumatic chest injury 10.Patients with severe multiple organ dysfunction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventilatory Parameters ( Peak airway pressure,	T1- 120 minutes after keeping on AC/VC corresponding to time just before switching to study ventilator mode 1 as per allocation. | T2- 60 minutes after keeping on ventilator mode 1 | T3- 120 minutes after keeping on ventilator mode 1 | T4- 120 minutes after switching back on AC/VC | corresponding to time just before switching to study ventilator mode 2 as per allocation. | T5- 60 minutes after keeping on ventilator mode 2 | T6- 120 minutes after keeping on ventilator mode 2
Platue pressure, Mean airway pressure, Mean	T1- 120 minutes after keeping on AC/VC corresponding to time just before switching to study ventilator mode 1 as per allocation. | T2- 60 minutes after keeping on ventilator mode 1 | T3- 120 minutes after keeping on ventilator mode 1 | T4- 120 minutes after switching back on AC/VC | corresponding to time just before switching to study ventilator mode 2 as per allocation. | T5- 60 minutes after keeping on ventilator mode 2 | T6- 120 minutes after keeping on ventilator mode 2
airway pressure, Compliance, Static compliance,	T1- 120 minutes after keeping on AC/VC corresponding to time just before switching to study ventilator mode 1 as per allocation. | T2- 60 minutes after keeping on ventilator mode 1 | T3- 120 minutes after keeping on ventilator mode 1 | T4- 120 minutes after switching back on AC/VC | corresponding to time just before switching to study ventilator mode 2 as per allocation. | T5- 60 minutes after keeping on ventilator mode 2 | T6- 120 minutes after keeping on ventilator mode 2
Airway resistance)	T1- 120 minutes after keeping on AC/VC corresponding to time just before switching to study ventilator mode 1 as per allocation. | T2- 60 minutes after keeping on ventilator mode 1 | T3- 120 minutes after keeping on ventilator mode 1 | T4- 120 minutes after switching back on AC/VC | corresponding to time just before switching to study ventilator mode 2 as per allocation. | T5- 60 minutes after keeping on ventilator mode 2 | T6- 120 minutes after keeping on ventilator mode 2

Secondary Outcome Measures

Name	Time	Method
1)Haemodynamic parameters-Systolic blood	pressure,Diastolic blood pressure,Mean arterial

Trial Locations

Locations (1)

Government Medical College and Hospital, Sector 32, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Government Medical College and Hospital, Sector 32, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Dr Akanksha Kumari

Principal investigator

8340611074

Singhakkusingh7@gmail.com