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CTRI Number  CTRI/2024/03/063874 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [VENTILATORY SUPPORT]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison of a new ventilation mode with conventional mode in patient requiring post operative ventilatory support after major abdominal surgery  
Scientific Title of Study   Comparison between Adaptive Support Ventilation and Traditional modes of mechanical ventilation SIMV combined with PSV in patients requiring postoperative elective ventilation after major abdominal surgeries a randomized controlled study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aman Kumar 
Designation  Academic Junior Resident 
Affiliation  Aiims Patna 
Address  Post Graduate Student Department Of Anesthesiology All India Institute Of Medical Sciences, Patna Bihar

Patna
BIHAR
801507
India 
Phone  8252314205  
Fax    
Email  bloodamansingh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Umesh Kumar Bhadani 
Designation  Professor 
Affiliation  AIIMS PATNA 
Address  Department of Anesthesiology Operation Theatre 5 floor All India Institute of Medical Sciences Patna Bihar

Patna
BIHAR
801507
India 
Phone  8969169123  
Fax    
Email  umeshbhadani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Umesh Kumar Bhadani 
Designation  Professor 
Affiliation  Aiims Patna 
Address  Department of Anesthesiology, OT Floor 5 All India Institute of Medical Sciences Patna Bihar

Patna
BIHAR
801507
India 
Phone  8969169123  
Fax    
Email  umeshbhadani@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Science Patna Bihar 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Patna Bihar 
Address  All India Institute of Medical Sciences Patna Bihar 
Type of Sponsor  Other [Self] 
 
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 
AMAN KUMAR  AIIMS PATNA PHULWARISHARIF BIHAR PIN 801507  Department Of Anesthesiology Surgical ICU 5th FLOOR OT Complex IPD building
Patna
BIHAR 		 8252314205

bloodamansingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE INSTITUTIONAL EHTICS COMMITTEE AIIMS PATNA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Simv Combined with Psv  All enrolled patients After the completion of surgery will be transferred to the ICU with tracheal intubation. simv combines with psv mode of ventilation will be applied with a target of weaning. A team of doctors comprising of Faculty, Senior Residents and Junior Resident involved in the study will be responsible for intervention and comparison.The total duration of the intervention will be shifting of patient in the ICU to extubation of patient. 
Intervention  adaptive support of ventilation  After the completion of surgery all enrolled patients will be transferred to the ICU with tracheal intubation where they will be managed according to a standardized protocol The interventor are Faculty, Senior Resident and Junior Residents posted in ICU. Comparator are same group of doctors involed in the study for two modes of ventilation. The total duration of the intervention will be shifting of patient in the ICU to extubation of patient. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age greater than 18 years
All patients who have undergone abdominal surgeries of duration more than 3 hrs under GA and requiring post operative mechanical ventilation.
BMI less than 40 Kg per m2
ASA Grade I and II

 
 
ExclusionCriteria 
Details  Patients with obstructive or restrictive pulmonary disease
Patients for re exploration surgeries
Patient with Ejection fraction less than 30 percent
Patient with gross electrolyte disturbance
Patient with severe bleeding episode during surgery

 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To measure and compare the duration of mechanical ventilation in patients undergoing elective abdominal surgeries on adaptive supportive ventilation and conventional modes of ventilation ie SIMV Mode  1st Point: Intubation in OT
2nd Point: End of Surgery which will indicate total duration of Surgery as end point in OT
3nd Point: Transfer in ICU.
4th Point: Removal of ET Tube ie Weaning. Duration of ventilation will be difference between admission time in ICU and extubation time ie known as weaning time from the entry into ICU 
 
Secondary Outcome  
Outcome  TimePoints 
To measure the rate of extubation failure
To measure the duration of ICU stay
To compare the Tidal Volume, RR, Peak Inspiraotry Pressures, Peak Airway pressure at the time of randomisation versus just before extubation.
To measure the PaO2 and FiO2 ratio just before and one hour after extubation
To measure and compare the lactate levels one hour post extubation
 		 1.5 years 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   18/03/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

After the completion of surgery, all enrolled patients will be transferred to the ICU with tracheal intubation, where they will be managed according to a standardized protocol. In both the study groups version of Hamilton C-3 (Hamilton Medical AG, Bonaduz, Switzerland) will be used. All enrolled patients will be electively ventilated as per standard sedation protocol using midazolam and fentanyl (Maintaining a RAAS Score between -2 and -3) using either ASV or conventional PSV and SIMV mode of ventilation as per randomisation.

Based on ABG analysis, if PH ranges between 7.35-7.45, P/F ratio > 150 and FiO2 < 40% and sedation will be stopped and the patient will be evaluated for potential weaning.

Good tolerance criteria and clinical stability (As per ACCP/ACCCM) will be evaluated every hour in terms of hemodynamic stability, normal mental status, no signs of anxiety,
no signs of somnolence, no signs of dyspnea and with an acceptable ABG (pH 7.35- 7.45, P/F ratio > 150, FiO2 < 40%, respiratory rate < 35 breaths/minute).

Mechanical ventilation will be returned to the previous step if any of the following occurs:

 Respiratory rate > 35 breaths/min
  Arterial oxygen saturation < 90%

 Heart rate > 140 beats/min or a sustained increase or decrease in the heart rate of more than 20%

 Systolic blood pressure > 200 mmHg or < 90 mmHg

 Agitation
  Diaphoresis
Arterial carbon dioxide tension (PaCO2) > 50 mmHg

Patients who successfully complete spontaneous breathing trial, with desirable ABG criteria shall be extubated and observed for the next 48 hours for any signs for failed extubation. Post extubation failure is defined as pH ≤ 7.35, an increase in arterial carbon dioxide > 15 mm Hg from value just prior to extubation, RR > 24 breaths/min and accessory muscle use.

  Data collection methods including settings and periodicity: Data will be collected and entered in google forms and proforma sheets, from patients’ admission to ICU until their discharge/transfer from the ICU.

    Statistical analysis: The data will be collected, assembled and analysed using Statistical Product and Service Solutions (SPSS version 20) software package for windows, Student Edition. The data will be collected over a period of one year. Results will be calculated after decoding the data.

 

 
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