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.

Comparison of Bi-level positive Airway Pressure versus Pressure-Regulated Volume Control mode of ventilation in exploratory laparotomy patients in intensive care unit

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049658

Enrollment

110

Registered

2023-02-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: To study the effects of BIPAP ventilatory mode in surgical patients in ICU.: Study the ventilatory and cardiopulmonary variables in patients undergoing Bi-level Positive Airway Pressure

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Ventilatory Parameters ( Peak airway pressure, Platue pressure, Mean airway pressure, Mean airway pressure, Compliance, Static compliance, 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. 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	—

Measure

Time frame

Ventilatory Parameters ( Peak airway pressure, Platue pressure, Mean airway pressure, Mean airway pressure, Compliance, Static compliance, 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. 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

Measure	Time frame
1)Haemodynamic parameters-Systolic blood pressure,Diastolic blood pressure,Mean arterial blood pressure,Heart rate,End -tidal cardon dioxide,Arterial oxygen saturation. 2)Arterial blood gas analysis parameters- pH, Partial pressure of oxygen, Partial pressure of 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. 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	—

Measure

Time frame

1)Haemodynamic parameters-Systolic blood pressure,Diastolic blood pressure,Mean arterial blood pressure,Heart rate,End -tidal cardon dioxide,Arterial oxygen saturation. 2)Arterial blood gas analysis parameters- pH, Partial pressure of oxygen, Partial pressure of 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. 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

—

Countries

India

Contacts

Public ContactDr Akanksha Kumari

Government Medical College and Hospital, Sector 32, Chandigarh

kapoor.dheeraj72@gmail.com9646121549

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026