FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/05/052412 [Registered on: 09/05/2023] Trial Registered Prospectively
Last Modified On: 04/05/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Single Arm Study 
Public Title of Study   Comparing ultrasonography and capnography to confirm endotracheal tube placement 
Scientific Title of Study   Accuracy of real time transtracheal ultrasonography and waveform capnography to detect endotracheal intubation – 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  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 Kadugondanahalli Bangalore KARNATAKA
Depaetment Of Anaesthesiology DR B R Ambedkar Medical College And Hospital Kadugondanahalli Bangalore KARNATAKA
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 Kadugondanahalli Bangalore KARNATAKA
Department OF Anaesthesiology DR B R Ambedkar Medical College And Hospital Kadugondanahalli Bangalore KARNATAKA
Bangalore
KARNATAKA
560045
India 
Phone  8928351213  
Fax    
Email  drng2105@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR HARSHITHA K 
Designation  POST GRADUATE 
Affiliation  DR B R Ambedkar Medical College 
Address  Department Of Anaesthesiology DR B R Ambedkar Medical College And Hospital Kadugondanahalli Bangalore KARNATAKA
Department Of Anaesthesiology DR B R Ambedkar Medical College AND Hospital Kadugondanahalli Bangalore KARNATAKA
Bangalore
KARNATAKA
560045
India 
Phone  9591688648  
Fax    
Email  dr.harshithasunil@gmail.com  
 
Source of Monetary or Material Support  
DR B R Ambedkar medical college and hospital 
 
Primary Sponsor  
Name  DR NEHA GUPTA 
Address  O.T COMPLEX, 1st floor Department of Anaesthesiology DR. B.R Ambedkar medical college and hospital Kadugondanahalli, Bangalore. 560045 
Type of Sponsor  Other [SELF SPONSORED] 
 
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  Dr B R Ambedkar medical college and hospital  O T COMPLEX Room no 1 1st Floor Department of Anaesthesiology DR B R Ambedkar Medical college and hospital Kadugondanahalli Bangalore 560045
Bangalore
KARNATAKA 		 8928351213

drng2105@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: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Capnography  Accuracy of waveform capnography to verify endotracheal intubation. After intubation capnographic readings will be noted down to confirm the correct placement of the endotracheal tube. Total time duration is based on the appearance of 6 capnographic waves to confirm the correct tube placement which is measured in seconds.  
Intervention  Transtracheal ultrasonography  Accuracy of real time transtracheal ultrasonography to verify endotracheal intubation. Real time transtracheal ultrasonography will be used during intubation to confirm the correct endotracheal tube placement in the trachea. Total time duration of the intervention depends on the time taken to correctly place the tube in the trachea, which is measured in seconds.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients posted for elective surgeries under general anaesthesia with oro-tracheal intubation.
2.Patients belonging to American society of anaesthesiologists physical status (ASA-PS)
I and II 
 
ExclusionCriteria 
Details  1. Patient with known predictors of difficult intubation.
2. BMI >30 KG/M2
3. Previous history of difficult intubation.
4. Failure to visualise glottic aperture in first attempt,or
5. Use of second attempt for tracheal 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 to detect endotracheal tube placement by transtracheal ultrasonography and capnography  To measure the time required to detect endotracheal tube placement by by transtracheal ultrasonography and capnography 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the reliability of transtracheal ultrasonography and capnography to detect the correct placement of endotracheal tube.   The appearance of 6 squared waveforms of more than 4mm of Hg in capnography confirms the correct placement of endotracheal tube which is measured in second from the time of beginning of intubation till the capnographic confirmation.  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   21/05/2023 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to drng2105@gmail.com.

  6. For how long will this data be available start date provided 02-02-2024 and end date provided 02-02-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Endotracheal intubation and securing airway is a crucial step in patient resuscitation whether in an emergency setting, intensive care unit (ICU) or operation theatre (OT). Endotracheal intubation can be difficult even for a skilled and experienced individual in certain cases. Any delay in confirmation of endotracheal tube placement can lead to life threatening complications like aspiration, cardiopulmonary arrest, hypoxemia and hypoxic brain injury ultimately leading to death, increasing both mortality and morbidity. Various techniques like visualization of vocal cords during laryngoscopy, fogging or misting of endotracheal tube, chest wall expansion following ventilation, visualization of tracheal rings and carina by bronchoscopy, chest auscultation to check for bilateral equal air entry, watching for abdominal distension, epigastric auscultation, oesophageal detector device, chest X-ray, capnometry or capnography and real time ultrasonography are available for confirmation of endotracheal tube placement. Capnography which is used for confirmation of correct placement of endotracheal tube can yield false positive results in cases of oesophageal intubation and also its dependency on pulmonary blood flow makes its accuracy questionable in pulmonary embolism, low cardiac output states and cases of cardiac arrest where the initiation of cardiopulmonary resuscitation (CPR) was delayed. It is also not readily available in settings like emergency room and intensive care unit (ICU) which imposes a major limitation. Portable ultrasonography machine (USG) is now widely available in all settings and can be made use for correct identification of endotracheal tube placement. Real time transtracheal ultrasonography is considered to be one of the newest and reliable modality. It is considered to be faster compared to capnography which is the gold standard method for endotracheal tube placement (ACLS 2015). Ultrasonography has various advantages such as non-invasiveness, cost effective, safety record, reproducibility of images and also the learning curve of ultrasonography has been found to be not so difficult. Hence, ultrasonography (USG) can be used as a potential alternative to capnography.  
Close