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CTRI Number  CTRI/2022/12/048314 [Registered on: 20/12/2022] Trial Registered Prospectively
Last Modified On: 19/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Single Arm Study 
Public Title of Study   Ultrasonography confirmation of endotracheal tube placement during general anaesthesia. 
Scientific Title of Study   Confirmation of endotracheal tube placement during general anaesthesia by ultrasonography. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR HARSHITHA K 
Designation  POST GRADUATE 
Affiliation  DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL KADUGONDANAHALLI BANGALORE

Bangalore
KARNATAKA
560045
India 
Phone  9591688648  
Fax    
Email  dr.harshithasunil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR HARSOOR S S  
Designation  PROFESSOR AND HEAD OF THE DEPARTMENT 
Affiliation  DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL KADUGONDANAHALLI BANGALORE

Bangalore
KARNATAKA
560045
India 
Phone  9845279426  
Fax    
Email  harsoorss@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR HARSOOR S S  
Designation  PROFESSOR AND HEAD OF THE DEPARTMENT 
Affiliation  DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL KADUGONDANAHALLI BANGALORE


KARNATAKA
560045
India 
Phone  9845279426  
Fax    
Email  harsoorss@gmail.com  
 
Source of Monetary or Material Support  
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  Dr Harshitha K 
Address  O.T COMPLEX, 1ST FLOOR DEPARTMENT OF ANAESTHESIOLOGY DR. B.R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL KADUGONDANAHALLI, BANGALORE. 560045 
Type of Sponsor  Other [] 
 
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 HARSHITHA K  DR. B R Ambedkar medical college  ROOM NO 1 O T COMPLEX DIVISION 1ST FLOOR DEPARTMENT OF ANAESTHESIOLOGY DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL KADUGONDANAHALLI BANGALORE 560045
Bangalore
KARNATAKA 
9591688648

dr.harshithasunil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B||Imaging, (2) ICD-10 Condition: B||Imaging, (3) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ULTRASONOGRAPHIC CONFIRMATION  ULTRASONOGRAPHY CONFIRMATION OF ENDOTRACHEAL TUBE PLACEMENT DURING GENERAL ANAESTHESIA IN PATIENT UNDERGOING ELECTIVE SURGERY. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.ALL PATIENTS POSTED FOR ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA WITH ORO TRACHEAL INTUBATION.
2.PATIENTS BELONGING TO ASA - PS I AND II. 
 
ExclusionCriteria 
Details  1.PATIENTS WITH KNOWN PREDICTORS OF DIFFICULT INTUBATION.
2. BMI MORE THAN 30KG/M2.
3. PREVIOUS HISTORY OF DIFFICULT INTUBATION. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
TO MEASURE THE TIME REQUIRED BY TANSTRACHEAL ULTRASONOGRAPHY TO CONFIRM THE ENDOTRACHEAL TUBE PLACEMENT.  FROM THE TIME OF LARYNGOSCOPY TILL THE TIME OF APPEARANCE OF BULLET SIGN ON ULTRASONOGRAPHY. 
 
Secondary Outcome  
Outcome  TimePoints 
DETERMINE THE RELIABILITY OF TRANSTRACHEAL ULTRASONOGRAPHY TO DETECT THE CORRECT PLACEMENT OF ENDOTRACHEAL TUBE.  TO DETERMINE THE RELIABILITY OF TRANSTRACHEAL ULTRASONOGRAPHY TO DETECT THE CORRECT PLACEMENT OF ENDOTRACHEAL TUBE. 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   22/12/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The cornerstone of airway management and resuscitation of patients is ‘rapid and accurate endotracheal tube placement’. Securing a definitive airway in any setting as in operation theatre, intensive care unit (ICU), emergency department is always a necessary.

Various methodologies like visualization of vocal cords during laryngoscopy followed by endotracheal tube placement, chest wall expansion following ventilation, visualization of tracheal rings and carina by bronchoscopy, chest auscultation, capnometry or capnography are available for confirmation of endotracheal tube placement. But there is no perfect modality for confirmation and very few methods are reliable.  Constant non-availability of these modalities is a major drawback.

The Advanced Cardiac Life Support (ACLS) 2015 guidelines recommend the usage of capnographic waveform along with clinical assessment for confirmation of endotracheal tube placement. Capnography is said to be the gold standard for confirmation which works on the principle of carbon dioxide detection, but has its own limitations like the availability in emergency departments and its dependency on adequacy of pulmonary blood flow makes it non reliable in conditions like pulmonary embolism, low cardiac output states, cardiac arrest (where cardiopulmonary resuscitation is not initiated/arrest for a prolonged period) and airway obstruction. False results have been noted when epinephrine was used.

Ultrasonography is now emerging as a promising tool for rapid assessment of endotracheal tube placement. Ultrasound machine is portable, widely available, non-invasive, cost effective, easy reproducibility of images and has good safety record. Moreover, its available in all settings like emergency department, ICU and operation theatre. Confirmation of endotracheal tube in the trachea is confirmed by absence of “ Snow storm sign” (disturbance of tracheal air-mucosa interface with comet tail artefacts) visualized in ultrasound. Learning curve of transtracheal ultrasound has also been observed to be not difficult. Hence it can be used as a potential alternative to capnography during non-availability or when there is compromise in carbon dioxide detection by capnography.

 
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