| CTRI Number |
CTRI/2024/08/073062 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How much time does it take for clear fluid of a fixed amount to empty from stomach of Children. |
|
Scientific Title of Study
|
Ultrasonographic assessment of gastric emptying after clear fluid intake in children scheduled for general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini Jha |
| Designation |
Post graduate student at dept of anaesthesia |
| Affiliation |
Vardhman Mmahavir medical college and Safdarjung Hospital |
| Address |
Department of Anesthesiology and Intensive care,VMMC and Safdarjung Hospital,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8054389941 |
| Fax |
|
| Email |
shalinijha141@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Rani Sharma |
| Designation |
Director Professor at Department of Anesthesia and Intensive Care |
| Affiliation |
Vardhman Mmahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care VMMC and Safdarjung Hospital,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8054389941 |
| Fax |
|
| Email |
drkavitadn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalini Jha |
| Designation |
Post graduate student at Department of Anaesthesia |
| Affiliation |
Vardhman Mmahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care,VMMC and Safdarjung Hospital,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8054389941 |
| Fax |
|
| Email |
shalinijha141@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia and Intensive Care,Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital, New Delhi, 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Shalini Jha |
VMMC and Safdarjung Hospital |
Department of Anesthesiology, VMMC and Safdarjung Hospital,New Delhi,110029
New Delhi
DELHI |
08054389941
shalinijha141@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC and Safdarjung Hospital |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients fulfilling the criteria of American Society of Anaesthesiologists Physical Status I, II children.
2)Children aged 3-10 years
|
|
| ExclusionCriteria |
| Details |
1) Patients with risk factors for delayed gastric emptying
2) Patient refusing for of fluid intake or ultrasound. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the gastric emptying time after giving 5ml/kg clear liquid by Ultrasonographic assessment |
Antral diameters to be measured at baseline,15mins,30 mins,45 mins,60 mins, 75 mins, 90 mins,105mins and 120mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing gastric volume at different time intervals after intake of clear fluids |
baseline, immediately after fluid intake, at 30 mins, 45mins, 60 mins, 75 mins, 90mins, 105mins and 120mins |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
10/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This study employs ultrasonography to evaluate time taken for gastric emptying in children aged between 3-10 years who have consumed clear fluids before undergoing general anesthesia. It aims to assess the minimum required fasting duration that does not change the outcome from conventional fasting duration in pediatric patients before anaesthesia. |