| CTRI Number |
CTRI/2024/03/063838 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Improving fasting duration for children undergoing CT scan |
|
Scientific Title of Study
|
Quality Improvement Project for optimization of pre-procedural fasting duration among children undergoing Computerized Tomography in a Tertiary Care Institute |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aakriti Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Dept of Anaesthesia and Intensive Care
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087007817 |
| Fax |
00911722744401 |
| Email |
aakriti1988.ag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aakriti Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Dept of Anaesthesia and Intensive Care
CHANDIGARH
160012
India |
| Phone |
7087007817 |
| Fax |
00911722744401 |
| Email |
aakriti1988.ag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aakriti Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Dept of Anaesthesia and Intensive Care
CHANDIGARH
160012
India |
| Phone |
7087007817 |
| Fax |
00911722744401 |
| Email |
aakriti1988.ag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research,Sector 12,Chandigarh |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research Chandigarh |
| Address |
Sector 12, Chandigarh, India |
| 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 Aakriti Gupta |
Postgraduate Institute of Medical Education and Research, Chandigarh |
CT scan suite, Department of Radiodiagnosis and Imaging,Advanced Paediatric Centre, PGIMER
Chandigarh
CHANDIGARH |
7087007817
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 |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Printed form with QR code |
A printed form with instructions regarding fasting and the procedure will be given to the parents/guardians along with CT requisition form at the fee deposition counter. The instructions will be in easy to understand English, Hindi and Punjabi. The form will also have a QR code which can be scanned by the parent/guardian with the help of their smart phone camera. The code scanning will open a document containing the fasting instructions in pictorial, written and audio form (in all the 3 languages). The duration will be 6 months. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing CT scan under sedation |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the percentage of children with fasting duration for clear liquids less than or equal to 6 hours in the second phase of the study. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be the incidence of cases with inadequate fasting duration. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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)
Modification(s)
|
Not Applicable |
| 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
|
A 2-part prospective interventional quality improvement project will be conducted among children undergoing CT scan under sedation. In first part, the existing protocol of verbal fasting instructions will be followed and fasting data will be collected. In the second part, along with verbal instructions, a printed form with QR code (leading to a document with pictorial instructions) will be given to the patients. The fasting data will be collected. |