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

• Conditions: Health Condition 1: O- Medical and SurgicalHealth Condition 2: K631- Perforation of intestine (nontraumatic)

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 Agitationâ??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 Berlinâ??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, <br/ ><br>Platue pressure, Mean airway pressure, Mean <br/ ><br>airway pressure, Compliance, Static compliance, <br/ ><br>Airway resistance)Timepoint: T1- 120 minutes after keeping on AC/VC corresponding to time just before switching to study ventilator mode 1 as per allocation. <br/ ><br>T2- 60 minutes after keeping on ventilator mode 1 <br/ ><br>T3- 120 minutes after keeping on ventilator mode 1 <br/ ><br>T4- 120 minutes after switching back on AC/VC <br/ ><br>corresponding to time just before switching to study ventilator mode 2 as per allocation. <br/ ><br>T5- 60 minutes after keeping on ventilator mode 2 <br/ ><br>T6- 120 minutes after keeping on ventilator mode 2

Secondary Outcome Measures

Name	Time	Method
1)Haemodynamic parameters-Systolic blood <br/ ><br>pressure,Diastolic blood pressure,Mean arterial <br/ ><br>blood pressure,Heart rate,End -tidal cardon <br/ ><br>dioxide,Arterial oxygen saturation. <br/ ><br>2)Arterial blood gas analysis parameters- pH, <br/ ><br>Partial pressure of oxygen, Partial pressure of <br/ ><br>carbon dioxide, Arterial oxygen saturation.Timepoint: T1- 120 minutes after keeping on AC/VC corresponding to time just before switching to study ventilator mode 1 as per allocation. <br/ ><br>T2- 60 minutes after keeping on ventilator mode 1 <br/ ><br>T3- 120 minutes after keeping on ventilator mode 1 <br/ ><br>T4- 120 minutes after switching back on AC/VC <br/ ><br>corresponding to time just before switching to study ventilator mode 2 as per allocation. <br/ ><br>T5- 60 minutes after keeping on ventilator mode 2 <br/ ><br>T6- 120 minutes after keeping on ventilator mode 2