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CTRI Number  CTRI/2024/01/062156 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 22/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Other (Specify) [Ventilation mode]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Adaptive support mode a new advanced mode versus routine conventional ventilation in ventilation of children requiring mechanical ventilation Trial 
Scientific Title of Study   Effect of Adaptive Support Ventilation when compared with Conventional Ventilation in mechanically ventilated children – A Randomized Control Trial 
Trial Acronym  ADVENT Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abinaya Kannan 
Designation  DM Pediatric Critical Care  
Affiliation  All India Institute of Medical Sciences  
Address  All India Institute of Medical Sciences Pediatric Intensive Care Unit Department of Pediatrics Tatiband Raipur Chhattisgarh 492099
Great Eastern Road Opposite Gurudwara Tatibandh Raipur Chhattisgarh 492099
Raipur
CHHATTISGARH
492099
India 
Phone  9501631704  
Fax    
Email  abinayak2010@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Manas anjan Sahoo 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences  
Address  All India Institute of Medical Sciences Pediatric Intensive Care Unit Department of Pediatrics Tatibandh, Raipur Chhattisgarh - 492099
Great Eastern Road, Opp. Gurudwara Tatibandh, Raipur Chhattisgarh - 492099
Raipur
CHHATTISGARH
492099
India 
Phone  7898368010  
Fax    
Email  drmrsahoo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Abinaya Kannan 
Designation  DM Pediatric Critical Care  
Affiliation  All India Institute of Medical Sciences  
Address  All India Institute of Medical Sciences Pediatric Intensive Care Unit Department of Pediatrics Tatibandh, Raipur Chhattisgarh - 492099
Great Eastern Road, Opp. Gurudwara Tatibandh, Raipur Chhattisgarh - 492099
Raipur
CHHATTISGARH
492099
India 
Phone  9501631704  
Fax    
Email  abinayak2010@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raipur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences  
Address  All India Institute of Medical Sciences, Raipur 
Type of Sponsor  Research institution 
 
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 Abinaya Kannan  Pediatric Intensive Care Unit, All India Institute of Medical Sciences  2nd floor, C block, ward - 3 Great Eastern Road, Opp. Gurudwara Tatibandh
Raipur
CHHATTISGARH 
9501631704

abinayak2010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences, Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adaptive support mode of ventilation  Patient after randomization will be started on adaptive support mode of ventilation a new mode of ventilation  
Comparator Agent  Routine mode of ventilation as per physicians discretion  Other modes of ventilation such as SIMV, Assist control, PRVC as per physician discretion 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Children from 1 month to ≤15 years of age with acute need for invasive mechanical ventilation inclusive of acute respiratory illness, congenital heart disease, post cardiac surgery, acute neurological diseases and multi-organ dysfunction by oral endotracheal tube  
 
ExclusionCriteria 
Details  Expected death within 24 hours of intubation
Refusal to consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Duration of ventilation  Till 28 days from the date of enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
Extubation failure
Length of PICU stay
Mortality
Oxygenation saturation index
 
Admission to PICU discharge 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   03/02/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Soon after admission to Pediatric Intensive Care unit, Department of Pediatrics, AIIMS, Raipur, the patient will undergo screening for enrollment based on inclusion & exclusion criteria. If the patient doesn’t meet the inclusion criteria, he/she will be excluded. After inclusion into the study informed consent will be obtained from the patient’s legal guardian. Once consent is obtained patient will be randomized using computer generated block randomization with concealed allocation. The primary details and the disease status of the patient will be recorded in both the groups. Patient in the intervention group will undergo adaptive support ventilation using Hamilton G5 ventilator. The patient will be monitored for synchrony of ventilation and improvement in oxygenation and carbon dioxide, then P/F ratio, oxygenation index, lung stress index. The tidal volume and RR generated by the ASV mode will be documented.  The time taken to achieve synchronous ventilation will be documented. In control group, the conventional ventilation therapy according to unit’s protocol will be followed. Patient will be monitored in both intervention and control group and when the patient is not able to maintain either ventilation or oxygenation in any group, we would opt to transfer them to rescue mode of ventilation which is HFOV or APRV mode. The primary and secondary outcome will be recorded and followed up until discharge or death or for the next 28 days whichever is earlier in both the groups. Then data recorded will be analyzed using SPSS latest version. 

 
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