| CTRI Number |
CTRI/2023/01/049278 [Registered on: 30/01/2023] Trial Registered Prospectively |
| Last Modified On: |
28/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
"Comparison of Airway Pressure Release Ventilation versus Pressure Regulated Volume Control mode of ventilation in the exploratory laparotomy patients in intensive care unit" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jasmine Kaur Narula |
| Designation |
Post Graduate Junior Resident Trainee |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Level 5, D Block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9988710158 |
| Fax |
|
| Email |
jazz9a5745@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dheeraj Kapoor |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Level 5, D Block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121549 |
| Fax |
|
| Email |
kapoor.dheeraj72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasmine Kaur Narula |
| Designation |
Post Graduate Junior Resident Trainee |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Level 5, D Block, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9988710158 |
| Fax |
|
| Email |
jazz9a5745@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Director Principal, Government Medical College and Hospital, Sector 32, Chandigarh-160030 |
|
|
Primary Sponsor
|
| Name |
Director Principal |
| Address |
Government Medical College and Hospital, Sector 32, Chandigarh-160030 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jasmine Kaur Narula |
Government Medical College and Hospital, Sector 32, Chandigarh, 160030 |
Department of Anaesthesia and Intensive care, D block 5th floor, GMCH 32, Chd
Chandigarh
CHANDIGARH |
9988710158
jazz9a5745@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Core Committee, GMCH, Chandigarh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 parameters in mechanically ventilated post-exploratory laparotomies patients on APRV mode of ventilation for a total duration of 10 hours in ICU. |
| Comparator Agent |
To study effects of PRVC (pressure regulated volume control) ventilatory mode in surgical patients in ICU |
To study ventilatory, hemodynamic, and arterial blood gas parameters in mechanically ventilated post-exploratory laparotomies patients on PRVC mode of ventilation for a total duration of 10 hours in ICU. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 Agitation–Sedation Scale (RASS) between 0 and -2 |
|
| ExclusionCriteria |
| Details |
1. 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.
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. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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).
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. |
| 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).
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. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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. |