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

Phase 4

Not yet recruiting

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

• Registration Number: CTRI/2023/01/049278
• Lead Sponsor: Director Principal

Brief Summary

Mechanical ventilation is applied as one of the life support interventions in post-surgical patients with acute respiratory failure in the intensive care unit. Mechanical ventilators are equipped with unique modes to achieve optimum cardiopulmonary functions. With various preset target values, the advanced modes automatically adjust according to the patient‘s mechanical and ventilatory parameters, hence known as closed-loop control modes. Airway pressure release ventilation (APRV) is designed to facilitate the constant recruitment of alveoli while reducing the probability of ventilator-induced lung injury; while Pressure-regulated volume control (PRVC) is a dual mode of mechanical ventilation that integrates volume and pressure-control ventilation and is also termed as volume-targeted synchronized mode. On search of literature, no previous studies have compared APRV with more establish PRVC mode of ventilation specifically in postoperative exploratory laparotomy patients requiring invasive mechanical ventilatory support. We hypothesize that post-exploratory laparotomy patients in the ICU requiring mechanical ventilation with distinct and complex cardiorespiratory pathophysiology will have superior efficacy and safety in terms of ventilatory and hemodynamic profile on advance APRV mode compared to volume-targeted PRVC mode, due to the unique intrinsic characteristics of the APRV mode.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-01-28
• Study Start: 2023-01-31

Recruitment & Eligibility

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

Inclusion Criteria

• 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 Agitation–Sedation Scale (RASS) between 0 and -2.

Exclusion Criteria

• Pregnant and morbidly obese patients (BMI>35) 2.
• Patient diagnosed with acute respiratory distress syndrome (ARDS) (Mild, Moderate, or Severe) according to Berlin‘s definition.
• 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.
• 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 (Ppeak), plateau pressure (Pplat), mean airway pressure (Pmean), compliance (C), static compliance (Cstat), airway resistance (Raw) will be recorded	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 Outcome Measures

Name	Time	Method
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 recorded	T1-2 hours after keeping the patient on A/C VCV for 2 hours (washing period).
Arterial Blood Gas parameters: pH, partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2), and arterial oxygen saturation percentage (SaO2)	T1-2 hours after keeping the patient on A/C VCV for 2 hours (washing period).

Trial Locations

Locations (1)

Government Medical College and Hospital, Sector 32, Chandigarh, 160030; 🇮🇳 Chandigarh, CHANDIGARH, India

Government Medical College and Hospital, Sector 32, Chandigarh, 160030

🇮🇳Chandigarh, CHANDIGARH, India

Dr Jasmine Kaur Narula

Principal investigator

9988710158

jazz9a5745@yahoo.com