| CTRI Number |
CTRI/2024/12/077902 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Complications in newborns undergoing operations for defects of windpipe and foodpipe |
|
Scientific Title of Study
|
Perioperative adverse events in neonatal surgery for tracheoesophageal fistula and esophageal atresia: A Prospective Observational Study in a tertiary care centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VAISHALI GUPTA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
4th Floor, Nehru Hospital, Department of Anaesthesia and Intensive Care, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09463218070 |
| Fax |
|
| Email |
vaishaligupta0671@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Indu Mohini Sen |
| Designation |
PROFESSOR |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room no 29, D -Block, Nehru Hospital, Department of Anaesthesia and Intensive Care, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009532 |
| Fax |
|
| Email |
indumohini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Indu Mohini Sen |
| Designation |
PROFESSOR |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room no 29, D-Block, Nehru Hospital, Department of Anaesthesia and Intensive Care, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009532 |
| Fax |
|
| Email |
indumohini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh, India, Pin code- 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh, India, Pin Code- 160012 |
| 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 Vaishali Gupta |
Post Graduate Institute of Medical Education and Research |
OT Complex, Block A, 6th floor, Advanced Pediatric Centre
Chandigarh
CHANDIGARH |
09463218070
vaishaligupta0671@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q391||Atresia of esophagus with tracheo-esophageal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates scheduled for surgery for tracheoesophageal fistula/ esophageal atresia |
|
| ExclusionCriteria |
| Details |
Parental refusal for participation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence of intraoperative adverse events in neonates undergoing surgical correction of tracheoesophageal fistula/esophageal atresia, including desaturation, difficult intubation, inability to ventilate, hypercarbia, hypocarbia, bradycardia, tachycardia, hypotension, hypothermia, and hypoglycemia. |
Every 5 minutes from start of anaesthesia till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To describe the anaesthetic technique used for neonates undergoing surgical repair of tracheoesophageal fistula/esophageal atresia.
• To study the occurrence of postoperative complications, including the need for mechanical ventilation, inotropes, & any redo surgeries.
• To examine the incidence of mortality within 6 weeks.
• To evaluate factors associated with intraoperative adverse events & mortality.
|
From end of surgery to 6 weeks post surgery |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/01/2025 |
| 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)
|
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 - NO
|
|
Brief Summary
|
This prospective study will be enrolling the neonates undergoing surgery for tracheoesophageal fistula and esophageal atresia. Incidence of perioperative adverse events will be seen Postoperative follow-up till 6 weeks for complications |