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CTRI Number  CTRI/2024/03/064852 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 15/03/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross over study 
Study Design  Single Arm Study 
Public Title of Study   Comparing diagnostic accuracy of two different ultrasound guided methods to confirm the position of endotracheal tube in patients undergoing elective surgery 
Scientific Title of Study   A prospective observational study to assess the diagnostic accuracy of suprasternal versus subxiphoid ultrasonography for endotracheal intubation in patients undergoing elective surgery 
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 Neha Gupta 
Designation  Assistant professor 
Affiliation  Dr B R Ambedkar Medical College and Hospital 
Address  Department of Anaesthesiology Dr B R Ambedkar Medical college and hospital K G Halli, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  8928351213  
Fax    
Email  drng2105@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neha Gupta 
Designation  Assistant professor 
Affiliation  Dr B R Ambedkar Medical College and Hospital 
Address  Department of anaesthesiology, Dr B R Ambedkar medical college and hospital K G Halli, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  8928351213  
Fax    
Email  drng2105@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neha Gupta 
Designation  Assistant professor 
Affiliation  Dr B R Ambedkar Medical College and Hospital 
Address  Department of Anaesthesiology, Dr B R Ambedkar medical college and hospital K G Halli, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  8928351213  
Fax    
Email  drng2105@gmail.com  
 
Source of Monetary or Material Support  
Dr B R Ambedkar medical college and hospital Bangalore 
 
Primary Sponsor  
Name  Dr Neha Gupta 
Address  Dr B R Ambedkar Medical College and hospital K G Halli Bangalore Bangalore 
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 Neha Gupta  OT COMPLEX  Dr B R Ambedkar medical college and hospital K G Halli, Bangalore 560045
Bangalore
KARNATAKA 
8928351213

drng2105@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTION ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients posted for elective surgery under general anaesthesia with endotracheal intubation.
Patients belonging to age between 18- 80 years of either gender.
Patients belonging to American Society of Anaesthesiologist’s physical status (ASA- PS) I and II patients.
 
 
ExclusionCriteria 
Details  An abnormal airway anatomy
Unanticipated difficult intubation
BMI more than 30 kg/m2
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the diagnostic accuracy of ultrasonography using suprasternal approach by identifying the passage of ET tube through trachea and subxiphoid approach by observing the diaphragmatic movements after endotracheal intubation to confirm the correct placement of ET tube compared to capnography  To compare the diagnostic accuracy of ultrasonography using suprasternal approach by identifying the passage of ET tube through trachea and subxiphoid approach by observing the diaphragmatic movements after endotracheal intubation to confirm the correct placement of ET tube compared to capnography 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   04/04/2024 
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="0"
Months="6"
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  

Safe airway management is a priority in clinical care. Endotracheal intubation is an essential skill in operating rooms, emergency department and intensive care units to safely secure a patient’s airway. Rapid confirmation of the correct ET tube placement is also important as incorrect placement is associated with adverse outcomes. Endotracheal intubation is associated with incorrect or displaced tubing in 6% to 25% of case  The best approach to confirm correct placement of ET tube is observation of tube passage through vocal cords, followed by chest and epigastric auscultation.  Although no single confirmation technique is completely reliable, continuous waveform capnography, along with clinical evaluation, has been recommended to detect expiratory CO2 as the most reliable method for confirming correct tube placement. Methods used to confirm ETT must have a sensitivity of 100% in order to properly identify the esophageal intubation. In recent times, limited number of studies have been performed to confirm the endotracheal intubation by ultrasonography, where the placement of ET tube can be indirectly assessed by observing the pleura or diaphragm movement. Ultrasound can be used as a reliable method for confirmation, without any limitation . This confirmation technique can be learned and practiced easily to reduce the hypoxia duration due to misplacement and prevent complications like aspiration.

The present study is focused on assessing the diagnostic accuracy of the two approaches of confirming the endotracheal intubation via ultrasonography ie, suprasternal approach where the passage of the ET tube through the trachea is observed and subxiphoid approach where diaphragmatic movements after endotracheal intubation are observed

 
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