FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
nil   
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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 
Close