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CTRI Number  CTRI/2024/06/069113 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 04/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Estimating the size of tracheal tube used for intubation in children using different regular methods undergoing surgical operations 
Scientific Title of Study   Prediction of endotracheal tube size using various conventional methods in paediatric surgical population. A comparative observational study  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rekha Bai 
Designation  Junior Resident 1 
Affiliation  Vijayanagara Institute of Medical Sciences 
Address  Department of Anaesthesiology Vijayanagara Institute of Medical Sciences, Ballari.
same as Address1
Bellary
KARNATAKA
583104
India 
Phone  8431001646  
Fax    
Email  rekharajputh13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rekha Bai 
Designation  Junior Resident 1 
Affiliation  Vijayanagara Institute of Medical Sciences 
Address  Department of Anaesthesiology Vijayanagara Institute of Medical Sciences, Ballari.
Same as Address 1
Bellary
KARNATAKA
583104
India 
Phone  8431001646  
Fax    
Email  rekharajputh13@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kiran Chand N 
Designation  Associate Professor  
Affiliation  Vijayanagara Institute of Medical Sciences 
Address  Department of Anaesthesiology Vijayanagara Institute of Medical Sciences, Ballari
Same as Address 1
Bellary
KARNATAKA
583104
India 
Phone  9845857056  
Fax    
Email  nkiranchand@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Vijayanagar institute of Medical sciences Ballari  
 
Primary Sponsor  
Name  Vijayanagar Institute of Medical Sciences 
Address  Cantonment, Ballari, Karnataka, India 583104 
Type of Sponsor  Government 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 Rekha Bai  Vijayanagar Institute of Medical Sciences  Department of Anaesthesiology Major OT Complex,Cantonment, Ballari, Karnataka, India.
Bellary
KARNATAKA 
8431001646

rekharajputh13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee , Vijayanagar institute of Medical sciences Bellary   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Endotracheal tube Size   different sized endotracheal tubes based on different formulas will be selected and which one will be correct fit will be selected 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  12.00 Day(s)
Gender  Both 
Details  All paediatric surgical population requiring general anesthesia
ASA I and II
Consenting parents 
 
ExclusionCriteria 
Details  Children with active respiratory infection
Children with laryngeal and tracheal pathologies
Congenital developmental disorders
Malformation associated with head and neck and face
Upper airway obstruction and previous surgeries on the airway 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Selecting best fit endotracheal tube based on Age Height and weight   Preintubation and at intubation  
 
Secondary Outcome  
Outcome  TimePoints 
To identify the most reliable formula for predicting ETT size in Indian pediatric surgical population  To identify the most reliable formula for predicting ETT size in Indian pediatric surgical population 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   01/07/2024 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The study will be conducted at the Department of Anaesthesiology and Critical Care, VIMS Ballari. The patients will be selected for the study depending on the inclusion and exclusion criteria. The complete data will be collected from the patients in a specially designed Case Record Form (CRF) which includes history of illness and detailed clinical examination and relevant investigations. Before subjecting the patients for investigations and andanaesthesia, written/informed consent will be obtained from each patient and /or parents or legal guardian. All children will be appropriately premedicated the previous night and the day of surgery. Children will be kept Nil by mouth 6 hours for solids and 2 hours for clear water.

After having done preoperative anesthesia drill and taking the child in to the operating theatre (OT) all basic monitors (ECG, SPO2,NIBP, ETCO2,TEMP ) will be attached and the OT temperature will be maintained between 24-26 degree Celsius. 

General anaesthesia will be induced with inhalational or intravenous induction agent and maintained with inhalational agent in oxygen nitrous oxide mixture. Following complete muscle relaxation after administration of appropriate muscle relaxant, the first attempt of endotracheal intubation was done with uncuffed tube size calculated based on Height {( ID(mm = (Height in Cm /30) + 2)}. Following intubation correct placement will be confirmed by end  tidal carbon dioxide ( ETCO2) trace  and five point  auscultation. Once the tube is secured ,the  leak pressure will be measured by closing the pressure relief valve and auscultating over the larynx. The absence of considerable leak at an airway pressure between 10 -25 cms of water is considered as appropriate size. If there is leak at airway pressure lower than 10 cmsH2O , then the size is considered as too small and will be replaced with a tube Size 0.5 mm more than that used . Similarly if there is no leak at all, at airway pressure of 25cms of H2O or more, tube is considered as too large and will be replaced with 0.5mm smaller size. After having secured appropriate tube ventilation will be continued according to the requirements as per normal settings. 

The final (actual) tube size used will be correlated with the size predicted by ABF, HBF and WBF as follows :

The ABF used will be as follows : Age in years /4 +4  (ID ) 
The HBF used will be as follows ( Used primary selection) : Height in Cms/ 30 +2 (ID)
The WBF used will be : weight in Kg/10 +3.5  (ID) 

Following extubation the children will be monitored  in PACU for sorethroatharseness of voice, cough, aspiration stridor or any other complications. 

 

Design of study

 

1. Observational - Prospective, single group 

 


The statistical package for social sciences ( SPSS ) version 26.0 will be used for statistical analysis. The quantitative variables will be expressed as mean with 95% confidence intervals (95% CI) and will be compared using paired â€˜t’ test. Data will be presented as mean ± S,number(%) as appropriate. Pearson correlation coefficient test for association of various parameters for selection of ETT and inter rater kappa static for strength of agreement. A p-value less than 0.05 was considered significant.

 
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