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CTRI Number  CTRI/2022/12/047979 [Registered on: 08/12/2022] Trial Registered Prospectively
Last Modified On: 02/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Other (Specify) [Hospital based case series]  
Study Design  Other 
Public Title of Study   To choose the correct size of windpipe using ultrasound. 
Scientific Title of Study   Accuracy of ultrasound to predict endotracheal tube size in paediatric patients: Hospital based case series study” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR RAMESH KOPPAL 
Designation  PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  S NIJALINGAPPA MEDICAL COLLEGE 
Address  PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY, S NIJALINGAPPA MEDICAL COLLEGE, BAGALKOT-587102
PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY, S NIJALINGAPPA MEDICAL COLLEGE, BAGALKOT-587102
Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR RAMESH KOPPAL 
Designation  PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  S NIJALINGAPPA MEDICAL COLLEGE 
Address  PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY, S NIJALINGAPPA MEDICAL COLLEGE, BAGALKOT-587102
PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY, S NIJALINGAPPA MEDICAL COLLEGE, BAGALKOT-587102
Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR ANUSHA N  
Designation  PG IN ANAESTHESIOLOGY 
Affiliation  S NIJALINGAPPA MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIOLOGY, S NIJALINGAPPA MEDICAL COLLEGE, BAGALKOT-587102
DEPARTMENT OF ANAESTHESIOLOGY, S NIJALINGAPPA MEDICAL COLLEGE, BAGALKOT-587102
Bagalkot
KARNATAKA
587102
India 
Phone  7899563950  
Fax    
Email  anushanarayan89@gmail.com  
 
Source of Monetary or Material Support  
S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL BAGALKOT 
 
Primary Sponsor  
Name  Dept of Anaesthesia 
Address  S N Medical college Bagalkot 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 RAMESH KOPPAL  S Nijalingappa medical college and HSK hospital   Paediatric OT complex, 1st floor.
Bagalkot
KARNATAKA 
9845504515

rameshkoppaldr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S NIJALINGAPPA MEDICAL COLLEGE AND HANAGAL SHRI KUMARESHWAR HOSPITAL AND RESEARCH CENTRE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ENDOTRACHEAL TUBE INTUBATION  subglottic measurement by ultrasound followed by intubation with appropriate size endotracheal tube. Duration: 18months 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1.Age group 2-6years.
2.ASA I-III
3.Elective surgeries under GA
 
 
ExclusionCriteria 
Details  1.Patient with any anticipated difficult airway.
2.Patient with any anatomical deformity of upper airway
3.Patient with previous surgery involving upper airway.
4.Patient with any obvious scars, mass, or ulcer which will interfere with ultrasound examination of neck.
5.Patient‘s attenders refusal to give consent.
6.Patient with history of previous prolonged intubation



 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
ultrasound guided estimated ETT size is accurate compared to conventional height and weight formula based calculated ETT size.  24 Hours 
 
Secondary Outcome  
Outcome  TimePoints 
ultrasound measured ETT size prevents the need of re attempts of intubation which may be harmful to the paediatric patients.  24 hours 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/12/2022 
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="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Selection of an optimal endotracheal tube size is crucial in pediatric patients  and are mainly done with the age , height based formula routinely  which fails to yield an accurate size ETT resulting in increase in need of reattempts in intubation causing acute and chronic airway injury . Ultrasound being one of the advanced, reliable  and feasible modality which helps in measuring appropriate ETT size. The aim of the study is to determine the accuracy of ultrasound to estimated the real-time ETT size and to prevent the  need of reintubation as it is dangerous to pediatric airway. Objectives of this study is :  To identify the accuracy of ultrasound in assessing the correct endotracheal tube size and to assess the number of attempts required to change the ultrasound estimated estimated endotracheal tube size based on air leak test. This is a hospital base case series study. Thirty ASA I-III patients of age 2-6 years under going elective surgery requiring general anaesthesia are choosen. After obtaining institutional  ethical clearance, written informed consent will be taken from patient’ s parents and guardians. After induction with general anaesthesia a real-time USG guided subglottic diameter will be measured. Initial ETT will be choosen according to measurement made using USG guidance and leak test is performed to determine the best fit ETT size. The study parameter are the external diameter(OD) of ETT and the  internal diameter of subglottic area measured by USG guidance.

 
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