| CTRI Number |
CTRI/2024/02/062566 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Heart Lung Machine duration used in open heart operations on oxygen level in the body by measuring the amount of Lung water using a Non-invasive monitor in children’s undergoing operation for closure of hole in the heart |
|
Scientific Title of Study
|
Effect of the duration of Cardiopulmonary bypass on oxygenation predicted by measuring thoracic fluid content (TFC) using electrical cardiometry in infants undergoing closure of ventricular septal defect (VSD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshay Harikanth Laguduva |
| Designation |
Senior Resident |
| Affiliation |
AIIMS |
| Address |
Department of Cardiac Anaesthesia and Critical Care
Cardiothoracic and Neuro centre,
AIIMS
Sri Aurobindo Marg,
Ansari nagar,
New Delhi
South
DELHI
110029
India |
| Phone |
9585522595 |
| Fax |
|
| Email |
aakshaylh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parag Gharde |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Department of Cardiac Anaesthesia and Critical care,
Cardiothoracic and Neuro Centre,
AIIMS
Sri Aurobindo Marg,
Ansari nagar,
New Delhi
DELHI
110029
India |
| Phone |
9319110404 |
| Fax |
|
| Email |
parag.gharde72@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshay Harikanth Laguduva |
| Designation |
Senior Resident |
| Affiliation |
AIIMS |
| Address |
Department of Cardiac Anaesthesia and Critical care,
Cardiothoracic and Neuro Centre,
AIIMS
Sri Aurobindo Marg,
Ansari nagar,
New Delhi
DELHI
110029
India |
| Phone |
9585522595 |
| Fax |
|
| Email |
aakshaylh@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Sri Aurobindo Marg, Ansari nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Sri Aurobindo Marg, Ansari nagar, New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Akshay Harikanth Laguduva |
AIIMS New Delhi |
Department of Cardiac Anaesthesia and Critical care Cardiothoracic and Neuro Centre
South
DELHI |
9585522595
aakshaylh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post-graduate research All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q210||Ventricular septal defect, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
infants between 1 month to 1 year, either sex, posted for elective surgical ventricular septal defect closure |
|
| ExclusionCriteria |
| Details |
Parents who had not given consent, redo surgery, Palliative surgery, complex VSD, Infants with preoperative respiratory dysfunction, Infants with heart failure, difficulty in placing electrodes due to local site infection, and syndromic infants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the change in Thoracic fluid content (TFC) using electrical cardiometry method with ICON monitor. |
Before and After cardiopulmonary bypass. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find a correlation between Thoracic fluid content (TFC) and its impact on oxygenation. |
Before and After cardiopulmonary bypass. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aakshaylh@gmail.com].
- For how long will this data be available start date provided 24-08-2025 and end date provided 24-07-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
For patients undergoing elective ventricular septal defect closure, the sensors of ICON monitor will be placed after induction and all Electrical Cardiometry parameters will be recorded along with blood gas analysis before and after coming off CPB |