| CTRI Number |
CTRI/2018/02/011687 [Registered on: 05/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
28/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Audit of sedation practices in children for CT scan |
|
Scientific Title of Study
|
Prospective Audit of Sedation/Anaesthesia practices for children undergoing Computerized Tomography in a Tertiary Care Institute |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aakriti Gupta |
| Designation |
Senior Resident |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Dept of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh
Dept of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160022
India |
| Phone |
8194800554 |
| Fax |
8194800554 |
| Email |
aakriti1988.ag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aakriti Gupta |
| Designation |
Senior Resident |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Dept of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh
Dept of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160022
India |
| Phone |
8194800554 |
| Fax |
8194800554 |
| Email |
aakriti1988.ag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aakriti Gupta |
| Designation |
Senior Resident |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Dept of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh
Dept of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160022
India |
| Phone |
8194800554 |
| Fax |
8194800554 |
| Email |
aakriti1988.ag@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Sector 12 , Chandigarh |
| 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 |
| Aakriti Gupta |
CT scan suite of Advanced Pediatric Centre |
PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
8194800554
8194800554
aakriti1988.ag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intramural |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All children undergoing CT scan, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
All children undergoing CT scan |
|
| ExclusionCriteria |
| Details |
Patients administered sedation by non-anaesthetist personnel |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sedation and monitoring practices |
Sep 2017 to Dec 2017 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Demographic variables, medications administered along with their doses, time from administration of sedative to the start of procedure, duration of procedure, recovery time, adverse events |
Sep 2017 to Dec 2017 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "263"
Final Enrollment numbers achieved (India)="263" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2017 |
| Date of Study Completion (India) |
31/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective observational cohort study was conducted to observe sedation and monitoring practices among children undergoing CT scan in our institute. |