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CTRI Number  CTRI/2018/03/012820 [Registered on: 23/03/2018] Trial Registered Retrospectively
Last Modified On: 19/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   agreement and time comparison of three techniques 
Study Design  Single Arm Study 
Public Title of Study   Use of ultrasound to confirm tube is correctly placed inside the wind pipe by trainee anaesthetist before surgery. 
Scientific Title of Study   The use of Ultrasound as a reliable tool for endotracheal intubation when performed by novice Anaesthesia residents- A prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Apala R Chowdhury 
Designation  Junior Resident, Department of Anaesthesiology, AIIMS, New Delhi 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 5011 Department of Anaesthesiology Academic Block All India Institute of Medical Sciences
All India Institute of Medical Sciences Ansari Nagar East New Delhi 110029
New Delhi
DELHI
110029
India 
Phone  9560730810  
Fax    
Email  apala.rc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Apala R Chowdhury 
Designation  Junior Resident, Department of Anaesthesiology, AIIMS, New Delhi 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 5011 Department of Anaesthesiology Academic Block All India Institute of Medical Sciences
All India Institute of Medical Sciences Ansari Nagar East New Delhi 110029
New Delhi
DELHI
110029
India 
Phone  9560730810  
Fax    
Email  apala.rc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jyotsna Punj 
Designation  Additional Professor, Department of Anaesthesiology, AIIMS, New Delhi 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 5013 Department of Anaesthesiology Academic Block All India Institute of Medical Sciences
All India Institute of Medical Sciences Ansari Nagar East New Delhi 110029
New Delhi
DELHI
110029
India 
Phone  9868397811  
Fax    
Email  jyotsna_punj@yahoo.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,Ansari nagar, New Delhi 110029 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences 
Address  All India Institute Of Medical Sciences Ansari Nagar East New Delhi-110029 
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 
Apala R Chowdhury  All India Institute Of Medical Sciences, New Delhi  Room no 5011, Department of Anesthesia, pain medicine and critical care, All India Institute Of Medical Sciences Ansari Nagar East New Delhi-110029
New Delhi
DELHI 		 9560730810

apala.rc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethics committee for post graduate research for clinical science  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients undergoing elective surgery requiring endotracheal intubation, ASA I-II, MP I-II, BMI 30,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -consenting patients posted for elective surgeries requiring general anaesthesia with oro-tracheal intubation
-BMI < 30kg/meter square
-first year Anaesthesiology residents (first 6 months and 6-12 months)  
 
ExclusionCriteria 
Details  -refusal to participate in the study
-predictors of difficult intubation
-modified mallampati class 3 and 4
-thyromental distance < 6.5cm
-upper lip bite test negative
-restricted neck movements (flexion <25
degrees, extension <85 degrees)
-previous history of difficult intubation
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
if ultrasound guided intubation is a reliable method of endotracheal intubation when performed by novice anesthetists  10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
to determine if ultrasound is the fastest method of confirmation of endotracheal intubation in comparison to chest ausculation and capnography.
whether it is a good indicator to guide the direction of endotracheal tube towards the trachea
 		 10 minutes 
whether it is a good indicator to guide the direction of endotracheal tube towards the trachea
 		 10 minutes 
 
Target Sample Size   Total Sample Size="103"
Sample Size from India="103" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/01/2015 
Date of Study Completion (India) 30/06/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   endotracheal intubation can be correctly identified by capnography and by chest ausculation. initially novice anesthetists may take longer time for performing the intubation . By the time the correct intubation is confirmed , precious time maybe lost resulting in morbidity of the patient including desaturation.
 the ideal method of teaching endotracheal intuabtion to the novice anesthetists would be one in which the mentor and the intubator can simultaneously visualize the airway. newer tools like videolaryngoscopes offer this however unfortunately these involve non conventional laryngoscopy methods and thus is not suitable for initial teaching tool for the novice anesthetists.
Thus , we hypothesize that ultrasound can be used as a tool for correct placement of the endotracheal tube in which simultanously the mentor can directly visualize the endotracheal tube placement and can even identify esophageal intubation.
this would also be fastest method of confirmation of endotracheal intubation as compared to capnography and chest auscultation.
 
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