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CTRI Number  CTRI/2024/10/075443 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To know the proper length of airway securing tube by measuring kids anatomical parameters like tragus length,foot length, sternum length, thyromental distance and so on. 
Scientific Title of Study   Association of Oro-tracheal tube inserted depth with anatomi-cal parameters among infants 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pappu Kumar Mahato 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  department of anaesthesia, Dhanvanthri Nagar,Puducherry
jipmer hostel complex , harvey house 2,room no. 211, jipmer, pondycherry
Pondicherry
PONDICHERRY
605006
India 
Phone  8797654097  
Fax    
Email  dr.mahato111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Lenin Babu Elakkumaran 
Designation  Proffesor and Head 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of anaethesia, Dhanvanthri Nagar,Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9487981140  
Fax    
Email  dr.lenin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pappu Kumar Mahato 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  department of anaesthesia, Dhanvanthri Nagar,Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8797654097  
Fax    
Email  dr.mahato111@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal institute of post graduate medical education and research  
 
Primary Sponsor  
Name  Jawaharlal institute of post graduate medical education and research 
Address  jawaharlal institute of post graduate medical education and research,(JIPMER), pondicherry, puducherry 
Type of Sponsor  Research institution and hospital 
 
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 Pappu Kumar Mahato   JIPMER HOSPITAL  NICU, PICU ,Pediatrics surgery OT, Emergency surgery OT; Pediatrics department ; Infantology devision, jipmer Hospital
Pondicherry
PONDICHERRY 
8797654097

dr.mahato111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J969||Respiratory failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  1.00 Year(s)
Gender  Both 
Details  Neonates and infants who undergoes an elective / emergency orotracheal intubation with tip of the ET tube in clinically effective position based on ET tube depth marker at the level of glottis. 
 
ExclusionCriteria 
Details  Infants with congenital anomalies of head and neck that complicate the ET tube intubation procedure are excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To measure the inserted depth of ET tube, nasotragal length, sternal length, foot length, thyromental length and manubriosternal junction to mental length and find out appropriate formulae for estimating the insertion depth of endotracheal tube using those parameters.  30 minutes to 1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
to develop a regression model to predict ET tube insertional depth using the anatomical parameters  at the time of intubation 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   25/10/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

:  Endotracheal intubation is a common procedure done in infants and neonates requiring respiratory support. More often this procedure is done in emergency setting, where predicting data such as weight of the patient may not be easy. After intubation, it is a standard medical practice to confirm the clinically effective position of the tip of the ET tube initially by chest auscultation and later by EtCO2. Optimal Endotracheal (ET) tube positioning is important, and the ideal position is halfway between vocal cord and carina. If an ET tube is placed too high accidental extubation may occur, if placed too low then endobronchial intubation, poor ventilation, atelectasis or pneumothorax may occur. The initial clinical assessment of the appropriate intubation depth is to auscultate equal  air entry to the bilateral lungs. Nevertheless, it lacks a quantitative or qualitative change of breathing sound detected on auscultation, despite 1cm downward displacement of the ET tube tip into the main bronchus; one study indicated that up to 60% of endobronchial intubations were by equal breath sound auscultation. Thus, several methods have been reported to determine the proper ET tube depth for  intubation and the accurate ET tube tip position, such as the well-known 7-8-9 Rule, body parameters as a predictor, the manufacturer’s markings on the tube tip and sonogram. Also, a number of nomograms are available to predict this depth from external body measurements such as weight, head circumference, crown-heel or crown-rump length. However, many of these studies have their limitations.

 
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