| CTRI Number |
CTRI/2023/05/052312 [Registered on: 04/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective comparative |
| Study Design |
Other |
|
Public Title of Study
|
A study for comparison of endo tracheal tube size used in clinical practice to size calculated by conventional formulas and by ultrasonography scans in Indian paediatric patients. |
|
Scientific Title of Study
|
A prospective study for comparison of endo tracheal tube size used in clinical practice to endo tracheal tube size calculated by conventional formulas and sub glottic diameter from ultrasonography scans in Indian paediatric patients in a tertiary care centre. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajashree Choudhury |
| Designation |
Primary DNB |
| Affiliation |
kokilaben dhirubhai ambani hospital and medical research centre. |
| Address |
Department of Anaesthesia,OT complex, Kokilaben Dhirubhai Ambani Hospital and medical research centre,
Four Bungalows, Andheri West,
Mumbai, India.
Mumbai
MAHARASHTRA
400053
India |
| Phone |
180030003333 |
| Fax |
912243366777 |
| Email |
m4majoni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hemlata Kapoor |
| Designation |
Consultant, dept of Anaesthesiology |
| Affiliation |
kokilaben dhirubhai ambani hospital and medical research centre. |
| Address |
Four Bungalows, Andheri West,
Mumbai, India.
Mumbai
MAHARASHTRA
400053
India |
| Phone |
180030003333 |
| Fax |
912243366777 |
| Email |
h_sarinkapoor@hotmail.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Rajashree Choudhury |
| Designation |
Primary DNB |
| Affiliation |
kokilaben dhirubhai ambani hospital and medical research centre. |
| Address |
Department of Anaesthesia, OT Complex, Kokilaben Dhirubhai Ambani Hospital and Medical research centre,Four Bungalows, Andheri West,
Mumbai, India.
Mumbai
MAHARASHTRA
400053
India |
| Phone |
180030003333 |
| Fax |
912243366777 |
| Email |
m4majoni@gmail.com |
|
|
Source of Monetary or Material Support
|
| kokilaben dhirubhai ambani hospital and medical research centre. |
|
|
Primary Sponsor
|
| Name |
kokilaben dhirubhai ambani hospital and medical research centre |
| Address |
Four Bungalows, Andheri West,
Mumbai, India. |
| 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 |
| Rajashree choudhury |
kokilaben dhirubhai ambani hospital and medical research centre |
Department of Anaesthesia, OT complex, Four Bungalows. andheri west,
Mumbai, India
Mumbai
MAHARASHTRA |
7896747374
m4majoni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Academics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z408||Encounter for other prophylactic surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
paediatric population
posted for elective surgeries
consented for ultrasonography scans.
ASA 1and 2 patients. |
|
| ExclusionCriteria |
| Details |
patient with history of allergy to ultrasound gel
patient in which mask ventilation could not be done.
patient with some other disease, cardiac anomalies, airway anomalies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the accuracy of Endo Tracheal tube size estimation in our Indian sub-
continent children using ultrasonography scan parameters and using classical formulas, the
latter being mainly derived from the western population. |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the size of cuffed Endo tracheal Tube used in children undergoing surgeries
requiring endo tracheal intubation and compare it while evaluating the tube size using
tracheal diameter measured by ultrasonography study and by classical formulas in Indian
paediatric patients. |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2023 |
| Date of Study Completion (India) |
15/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Radiological assessment of tracheal dimensions can be done by chest radiographs, ultrasound scans. Out of all these, Ultra sound is a portable, easy to use, readily available, non-invasive method of doing airway assessment with a high sensitivity. The diameter of the sub glottic region calculated from ultrasonography of the anterior neck region, which is the narrowest part of the trachea corresponds to the outer diameter of the endo tracheal tube. In our hospital, pediatric patients undergoing elective surgeries can have their preoperative ultra sound scans done, especially during the period of mask ventilation, when the patient is in a neck extended, head flexed position. The majority of these surgeries include cochlear implant surgeries, along with the other surgeries. |