| CTRI Number |
CTRI/2018/03/012443 [Registered on: 09/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate peri-operative problems of upper airway in children undergoing repair of cleft lip and palate. |
|
Scientific Title of Study
|
Evaluation of peri-operative airway compromise in children undergoing repair of cleft lip and / or palate |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ratna Kumar |
| Designation |
Junior resident |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Anaesthesia office 5th floor Nehru hospital PGIMER chandigarh
Sec 12 chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9592914802 |
| Fax |
|
| Email |
ratnakumar4802@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PREETY J MATHEW |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
PGIMER |
| Address |
DEPT OF ANAESTHESIA 5TH FLOOR NEHRU HOSPITAL, PGIMER SEC-12,CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009530 |
| Fax |
|
| Email |
tjpreethy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PREETY J MATHEW |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
PGIMER |
| Address |
DEPT OF ANAESTHESIA 5TH FLOOR NEHRU HOSPITAL, PGIMER SEC-12 CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009530 |
| Fax |
|
| Email |
tjpreethy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate institute of medical education and research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER, 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 Ratna Kumar |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
Department of Anaesthesia and Intensive Care,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9592914802
ratnakumar4802@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cleft Lip and or Palate children, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with cleft lip or palate- unilateral or bilateral.
2. Age 0-12 yrs
3. ASA I and ASA II
4. Scheduled for elective repair of lip and/or palate under GA.
5. Children with or without obvious external anatomical variations.
|
|
| ExclusionCriteria |
| Details |
1. Severe cardiac or respiratory co-morbidity
2. ASA III |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the thickness of tongue, pre-repair and post-repair, ultrasonographically. |
After induction(before intubation) and after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Airway assessment including measurements of airway distance viz. sternomental distance,thyromental distance,and mentohyoid distance. |
Pre-operatively in the ward(one day before surgery). |
| To assess the incidence of pre-opeprative and post-operative airway compromise in CLP children |
Peri-operative period(until 2 hours after surgery). |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/11/2015 |
| Date of Study Completion (India) |
31/10/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet-under process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
we propose to undertake a study to evaluate the airway in infants and children scheduled for cleft lip palate repair involving clinical and ultrasonography measurements to document the changes that occur in tongue thickness after repair of cleft palate. |