| CTRI Number |
CTRI/2019/01/017232 [Registered on: 24/01/2019] Trial Registered Prospectively |
| Last Modified On: |
23/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Airway complications in children undergoing cleft lip and palate surgery |
|
Scientific Title of Study
|
Factors determining airway complications in children undergoing cleft lip and palate surgery: A multivariate analysis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandhya Yaddanapudi |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh. |
| Address |
Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872005576 |
| Fax |
|
| Email |
sandhya.yaddanapudi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandhya Yaddanapudi |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh. |
| Address |
Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872005576 |
| Fax |
|
| Email |
sandhya.yaddanapudi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aindala Prathyusha |
| Designation |
PG student |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh. |
| Address |
Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8330990105 |
| Fax |
|
| Email |
aindalaprathyusha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| 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 |
| Dr Sandhya Yaddanapudi |
Nehru Hospital, PGIMER |
PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9872005576
sandhya.yaddanapudi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q188||Other specified congenital malformations of face and neck, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children undergoing cleft lip or cleft palate surgery. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Airway complications |
Intraoperative and postoperative period up to 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recovery from anaesthesia, postoperative bleeding, hypothermia, vomiting |
Postoperative period up to 24 hours |
|
|
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)
|
28/01/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/10/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the study is to prospectively evaluate the preoperative and intraoperative factors determining perioperative complications in children undergoing cleft lip and palate surgery. |