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To compare the effects of two modes of ventilation (airway pressure release ventilation and pressure regulated volume control) in surgical patients admitted in icu requiring ventilator support

"Comparison of Airway Pressure Release Ventilation versus Pressure Regulated Volume Control mode of ventilation in the exploratory laparotomy patients in intensive care unit"

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049278
Enrollment
110
Registered
2023-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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 effects of invasive ventilatory mode- APRV (Airway pressure release ventilation) in surgical patients in ICU: To study ventilatory, hemodynamic, and arterial blood gas paramet

Sponsors

Director Principal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients on invasive mechanical ventilation and admitted in ICU following exploratory Laparotomy due to acute respiratory failure (ARF) for less than 24 hours 2. Age group 18-60 years 3. Stable hemodynamic parameters (Mean Arterial Pressure between 70 mm Hg and 100 mm Hg, heart rate between 60 and 100/minute, SPO2 >= 90%) 4. Richmond Agitationâ??Sedation Scale (RASS) between 0 and -2

Exclusion criteria

Exclusion criteria: 1. Pregnant and morbidly obese patients (BMI >35) 2. Patient diagnosed with acute respiratory distress syndrome (ARDS) (Mild, Moderate, or Severe) according to Berlinâ??s definition. 3. Patients with severe or chronic heart, lung, hepatic or renal disease 4. Patients with severe neuromuscular disorders 5. Patient on vasopressors, cardiac depressants or neuromuscular blockers 6. Patient with traumatic brain injury 7. Patient with blunt or traumatic chest injury 8. Patients with severe multiple organ dysfunction.

Design outcomes

Primary

MeasureTime frame
Ventilatory parameters: Peak airway pressure (Ppeak), plateau pressure (Pplat), mean airway pressure (Pmean), compliance (C), static compliance (Cstat), airway resistance (Raw) will be recordedTimepoint: T1-2 hours after keeping the patient on A/C VCV for 2 hours (washing period). T2-2 hours after shifting on A/C VC mode from its original mode of ventilation (corresponding to time just before switching to study ventilatory mode). T3-4 hours after shifting on study mode (APRV or PRVC) as per group allocation. T4-6 hours after shifting on study mode (APRV or PRVC) as per group allocation. T5-8 hours after shifting on study mode (APRV or PRVC) as per group allocation.

Secondary

MeasureTime frame
Arterial Blood Gas parameters: pH, partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2), and arterial oxygen saturation percentage (SaO2)Timepoint: T1-2 hours after keeping the patient on A/C VCV for 2 hours (washing period). T2-2 hours after shifting on A/C VC mode from its original mode of ventilation (corresponding to time just before switching to study ventilatory mode). T3-4 hours after shifting on study mode (APRV or PRVC) as per group allocation. T4-6 hours after shifting on study mode (APRV or PRVC) as per group allocation. T5-8 hours after shifting on study mode (APRV or PRVC) as per group allocation.;Hemodynamic parameters: Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), end-tidal carbondioxide (EtCO2), percentage of oxygen saturation by pulse oximetry (SpO2), ratio of oxygen saturation to fraction of inspired oxygen (SPO2/FIO2) and urine output will be recordedTimepoint: T1-2 hours after keeping the patient on A/C VCV for 2 hours (washing period). T2-2 hours after shifting on A/C VC mode from its original mode of ventilation (corresponding to time just before switching to study ventilatory mode). T3-4 hours after shifting on study mode (APRV or PRVC) as per group allocation. T4-6 hours after shifting on study mode (APRV or PRVC) as per group allocation. T5-8 hours after shifting on study mode (APRV or PRVC) as per group allocation.

Countries

India

Contacts

Public ContactDr Jasmine Kaur Narula

Government Medical College and Hospital

kapoor.dheeraj72@gmail.com9646121549

Outcome results

None listed

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