| CTRI Number |
CTRI/2018/05/013755 [Registered on: 08/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
01/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
STUDY FOR CORRECT ENDOTRACHEAL TUBE SIZE PREDICTION IN CHILDREN |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF DIFFERENT FORMULAE FOR PREDICTION OF BEST FIT ENDOTRACHEAL TUBE SIZE IN CHILDREN |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SATHEESKUMAR S |
| Address |
LADY HARDINGE MEDICAL COLLEGE, DEPARTMENT OF ANESTHESIA, OPPOSITE TO SHIVAJI STADIUM, SHAHEED BHAGAT SINGH MARG
Central
DELHI
110001
India |
| Phone |
7598130819 |
| Fax |
|
| Email |
mdummc@gmail.com |
|
Details Contact Person
Scientific Query
|
| Name |
DR MAITREE PANDEY |
| Address |
LADY HARDINGE MEDICAL COLLEGE, DEPARTMENT OF ANESTHESIA, OPPOSITE TO SHIVAJI STADIUM, SHAHEED BHAGAT SINGH MARG
Central
DELHI
110001
India |
| Phone |
9810570515 |
| Fax |
|
| Email |
maitreepandey@gmail.com |
|
Details Contact Person
Public Query
|
| Name |
DR MAITREE PANDEY |
| Address |
LADY HARDINGE MEDICAL COLLEGE, DEPARTMENT OF ANESTHESIA, OPPOSITE TO SHIVAJI STADIUM, SHAHEED BHAGAT SINGH MARG
Central
DELHI
110001
India |
| Phone |
9810570515 |
| Fax |
|
| Email |
maitreepandey@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| LADY HARDINGE MEDICAL COLLEGE, DEPARTMENT OF ANESTHESIA, OPPOSITE TO SHIVAJI STADIUM, SHAHEED BHAGAT SINGH MARG, CENTRAL DELHI, 110001, INDIA |
|
Primary Sponsor
Modification(s)
|
| Name |
LADY HARDINGE MEDICAL COLLEGE |
| Address |
LADY HARDINGE MEDICAL COLLEGE, DEPARTMENT OF ANESTHESIA, OPPOSITE TO SHIVAJI STADIUM, SHAHEED BHAGAT SINGH MARG, CENTRAL DELHI, 110001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SATHEESKUMAR S |
LADY HARDINGE MEDICAL COLLEGE |
LADY HARDINGE MEDICAL COLLEGE, DEPARTMENT OF ANESTHESIA, OPPOSITE TO SHIVAJI STADIUM, SHAHEED BHAGAT SINGH MARG
Central
|
7598130819
mdummc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LHMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CHILDREN UNDERGOING SURGERY UNDER GENERAL ANESTHESIA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
CHILDREN AGED 1 TO 10 YEARS OF EITHER SEX
|
|
| ExclusionCriteria |
| Details |
1)CHILDREN WITH KNOWN LARYNGEAL AND TRACHEAL PATHOLOGY
2)UPPER AIRWAY OBSTRUCTION
3)HISTORY OF TRACHEOSTOMY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PROPORTION OF CHILDREN IN WHOM BEST FIT UNCUFFED ENDOTRACHEAL TUBE SIZE WILL BE PREDICTED BY USING EACH OF HEIGHT, AGE AND WEIGHT BASED FORMULAE |
DURING INTRAOPERATIVELY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PROPORTION OF PATIENTS DEVELOPING SORE THROAT, HOARSENESS OF VOICE, COUGH, STRIDOR, DYSPNOEA, ASPIRATION AND ANY OTHER ENDOTRACHEAL INTUBATION RELATED COMPLICATIONS |
DURING POSTOPERATIVELY |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/11/2017 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NOT YET |
|
Brief Summary
|
MOST STUDIES TO CALCULATE SIZE OF PAEDIATRIC ENDOTRACHEAL TUBE SIZE ARE BASED ON WESTERN PAEDIATRIC POPULATION WITH PAUCITY OF LITERATURE VALIDATING THESE STUDIES TO INDIAN CHILDREN. SO THE PRESENT STUDY HAS BEEN PLANNED TO COMPARE EACH OF HEIGHT, AGE AND WEIGHT BASED METHODS TO PREDICT BEST FIT ENDOTRACHEAL TUBE SIZE IN INDIAN CHILDREN.
|
