| CTRI Number |
CTRI/2011/06/001847 [Registered on: 30/06/2011] Trial Registered Prospectively |
| Last Modified On: |
20/01/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasonography derived formula to predict endotracheal tube size in pediatric patients
|
|
Scientific Title of Study
|
Validation of Ultrasonography derived formula to predict endotracheal tube size in pediatric patients
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RS/MSSH/SKT-1/AD/11-018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta Sethi |
| Designation |
Attending Consultant |
| Affiliation |
Department Of Anaesthesiology and Pain managementMax Super Speciality Hospital Saket New Delhi |
| Address |
Department Of Anaesthesiology and Pain management
Max Super Speciality Hospital
2 press enclave road Saket New Delhi
New Delhi DELHI 1100017 India |
| Phone |
|
| Fax |
|
| Email |
mittaldrmamta@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mamta Sethi |
| Designation |
Attending Consultant |
| Affiliation |
Department Of Anaesthesiology and Pain managementMax Super Speciality Hospital Saket New Delhi |
| Address |
Department Of Anaesthesiology and Pain management
Max Super Speciality Hospital
2 press enclave road Saket New Delhi
New Delhi DELHI 1100017 India |
| Phone |
|
| Fax |
|
| Email |
mittaldrmamta@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mamta Sethi |
| Designation |
Attending Consultant |
| Affiliation |
Department Of Anaesthesiology and Pain managementMax Super Speciality Hospital Saket New Delhi |
| Address |
Department Of Anaesthesiology and Pain management
Max Super Speciality Hospital
2 press enclave road Saket New Delhi
New Delhi DELHI 1100017 India |
| Phone |
|
| Fax |
|
| Email |
mittaldrmamta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology and Pain management Max Super Speciality Hospital
Saket New Delhi
|
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesiology and Pain managemenMax Super Speciality Hospital Saket New Delhi |
| Address |
Max Super Speciality Hospital 2 press enclave road
Saket New Delhi 1100017
|
| 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 Mamta Sethi |
Department Of Anaesthesiology and Pain management Max Super Speciality Hospital Saket New Delhi |
Max Super Speciality Hospital 2 press enclave road Saket New Delhi 1100017 New Delhi DELHI |
09717494499
mittaldrmamta@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Paediatric patients undergoing elective surgery under general anaesthesia requiring intubation with cuffed endotracheal tube, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female
2. Age full term neonate to 10 years
3. ASA physical status I-II
|
|
| ExclusionCriteria |
| Details |
1. History or physical evidence of intrinsic or extrinsic airway obstruction
2. History of upper or lower respiratory tract infection
3. Patients requiring nasotracheal intubation
4. Patients requiring intubation with uncuffed endotracheal tube
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the rate of agreement between the clinically optimal and the predicted endotracheal tube size as determined by the regression formula based on ultrasonography of the paediatric airway |
From induction of anaesthesia to intubation of trachea with a cuffed endotracheal tube |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the rate of agreement between the clinically optimal and the predicted endotracheal tube size as determined by the age based formula
|
From induction of anaesthesia to intubation of trachea with a cuffed endotracheal tube |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
15/07/2011 |
| 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="1" Months="6" Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Determination of appropriate sized endotracheal tube is
essential in children. Intubation
of pediatric patients with an endotracheal tube (ETT) that is too small may
result in insufficient ventilation, poor reliability of end-tidal gas
monitoring, leakage of anesthetic gases into the operating room environment,
and an enhanced risk of aspiration. In contrast, an ETT that is
too large can cause upper airway damage (e.g., local ischemia, ulceration,
scar formation) and the potential for subsequent subglottic stenosis. Age-based formulas are commonly used to
estimate optimal ETT size. Predictive formulas for appropriate ETT
size have also been based on patient weight and height. However, none of these
formulas are able to determine the appropriate size of the endotracheal tube
with great accuracy. Studies
have shown that agreement rate of these formulas for determining the
appropriate endotracheal tube size in paediatric patients is as low as 47-77%. The result is that repeated laryngoscopies
are often necessary to identify the appropriate tube for individual patients.
Recent reports suggest that the diameter of the subglottic upper airway can be
determined by ultrasonography in young adults and pediatric patients. A new regression formula based on measurement of subglottic diameter by
ultrasonography has been formulated by Shibasaki et al. Unlike the
age based formulas , not many studies have been done to evaluate the agreement rate of the endotracheal tube size
determined clinically and that determined
by formula based on ultrasonography.
In
our study we aim to determine the rate of agreement between the clinically optimal
and the predicted endotracheal tube size as
determined by the regression formula based on ultrasonography of the
paediatric airway |