| CTRI Number |
CTRI/2022/03/041513 [Registered on: 31/03/2022] Trial Registered Prospectively |
| Last Modified On: |
30/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Perioperative outcomes in children undergoing surgical procedures in different speciality specific operating rooms of a tertiary care institute: |
|
Scientific Title of Study
|
PERIOPERATIVE OUTCOMES OF SURGICAL PROCEDURES IN CHILDREN
IN SPECIALITY-SPECIFIC NON-PAEDIATRIC OPERATING ROOMS
OF A TERTIARY CARE INSTITUTE: AN OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M S ADITYA PRASAD |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER |
| Address |
4TH FLOOR
ANAESTHESIA OFFICE
NEHRU HOSPITAL
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
adityamulavisala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
INDU MOHINI SEN |
| Designation |
PROFESSOR |
| Affiliation |
PGIMER |
| Address |
ANAESTHSIA OFFICE
4TH FLOOR
NEHRU HOSPITAL
PGIMER SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009532 |
| Fax |
|
| Email |
indumohini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M S ADITYA PRASAD |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER |
| Address |
ANAESTHESIA OFFICE
4TH FLOOR
NEHRU HOSPITAL
PGIMER
SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
adityamulavisala@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER hospital sector 12 dept of Anaesthesia and intensive care |
|
|
Primary Sponsor
|
| Name |
NONE POST GRADUATE THESIS |
| Address |
Department of Anaesthesia and Intensive Care
PGIMER
SECTOR 12 |
| Type of Sponsor |
Other [NO FUNDING] |
|
|
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 Aditya Prasad |
PGIMER |
5th floor
PGIMER nehru hospital
sector 12
Chandigarh
CHANDIGARH |
8309494345
adityamulavisala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER IEC |
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
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
children of the age group 0 to 13 being operated in the ENT, NEUROSURGERY and PLASTIC SURGERY theatres |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patient has been discharged from the post anaesthesia care unit |
from 1/4/22 to 28/2/23 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient suffered a critical event intraoperative whivh required escalation of care at which point the end point becomes the point of discharge from hospital |
2/4/22-1/3/23 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
02/04/2022 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this observational study is to follow perioperative outcomes of children of the age group 0-12 years being operated in Elective operation theatres. The outcomes will be assessed in terms of preoperative fluid therapy, pediatric parental satisfaction score and preoperative COLDS score for URI. The data collected shall be obtained by follow up of the patient till an end point of anaesthetic care, and Escalation of care in terms of prolonged endotracheal intubation, performing CPR, shall be included. |