| 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
|
|
|
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
|
|
|
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. |