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CTRI Number  CTRI/2021/05/033595 [Registered on: 13/05/2021] Trial Registered Prospectively
Last Modified On: 12/05/2021
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 a conventional and an advanced mode of ventilator on surgical patients admitted in ICU 
Scientific Title of Study   A comparison of ventilatory and cardiopulmonary variables in surgical patients undergoing synchronized intermittent mandatory ventilation-volume control and pressure-regulated volume control 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 Deepanshu Rai 
Designation  Post Graduate Junior Resident Trainee 
Affiliation  Government Medical College and Hospital, Sector 32, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Level 5, Block D, Government Medical College and Hospital, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9877803239  
Fax    
Email  depanshurai@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dheeraj Kapoor 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Sector 32, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Level 5, Block D, 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 Deepanshu Rai 
Designation  Post Graduate Junior Resident Trainee 
Affiliation  Government Medical College and Hospital, Sector 32, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Level 5, Block D, Government Medical College and Hospital, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9877803239  
Fax    
Email  depanshurai@gmail.com  
 
Source of Monetary or Material Support  
Director Principal, Government Medical College and Hospital, SECTOR 32, Chandigarh 
 
Primary Sponsor  
Name  Director Principal Government Medical College and Hospital Chandigarh 
Address  Government Medical College and Hospital, Sector 32, Chandigarh-160030 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepanshu Rai  Government Medical College and Hospital, Sector-32, Chandigarh  Department of Anaesthesia and Intensive Care, Level 5, Block D, Government Medical College and Hospital, Sector-32
Chandigarh
CHANDIGARH 		 9877803239

depanshurai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Core Committee, GMCH, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pressure regulated volume control mode of ventilation  After putting the patient on PRVC mode ventilatory and cardiopulmonary variables would be assessed at specific time points.  
Comparator Agent  Synchronized intermittent mandatory ventilation-volume control   After putting the patient on SIMV mode ventilatory and cardiopulmonary variables would be assessed at specific time points  
 
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 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 Agitation–Sedation Scale (RASS)between 0 and -2
 
 
ExclusionCriteria 
Details  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 Berlin’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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Ventilatory Parameters ( Peak airway pressure, Platue pressure, Mean airway pressure, Mean airway pressure, Compliance, Static compliance, Airway resistance)  T1-Two hours after keeping on A/C VC mode just before switching to study mode (as per group allocation).
T2-Four hours after switching on study mode
T3-Twelve hours after switching on study mode

 
 
Secondary Outcome  
Outcome  TimePoints 
1) Haemodynamic Parameters-
Systolic Blood Pressure, Diastolic Blood Pressure, mean Arterial Pressure, End Tidal Carbon Dioxide, Oxygen Saturation as per Pulse Oximetry.
2) Arterial Blood Gas Analysis Parameters-
Partial Pressure of Oxygen in Arterial Blood, Partial Pressure of Carbon Dioxide in Arterial Blood, Oxygen Saturation in Arterial Blood, pH  		 T1-Two hours after keeping on A/C VC mode just before switching to study mode (as per group allocation).
T2-Four hours after switching on study mode
T3-Twelve hours after switching on study mode

 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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)   20/05/2021 
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   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Mechanical ventilation involves close interactions between different variables such as pressure, flow, volume and time for optimal gas exchange. Conventional ventilators have inability to adjust ventilation according to the patient’s variables. Newer modes of ventilators circumvent the aforesaid drawback by making automatic adjustments according to the patient’s mechanical and ventilatory parameters. Pressure-regulated volume control (PRVC) mode is one of the newer advance mode of ventilation which integrates volume and pressure control ventilation. On search of literature, there are no existing studies comparing the effect of PRVC mode with conventional mode of ventilation such as synchronized intermittent mandatory ventilation-volume control (SIMV), specifically in post-exploratory laparotomy patients requiring mechanical ventilatory support. The aim of the present randomized prospective double blinded study is to compare the ventilatory and cardiopulmonary variables in post exploratory laparotomy patients admitted to intensive care unit.  

 
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