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CTRI Number  CTRI/2023/02/049926 [Registered on: 21/02/2023] Trial Registered Prospectively
Last Modified On: 20/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the suitable method to confirm the placement of the breathing tube in the throat. 
Scientific Title of Study   A comparative study to assess transtracheal sonography versus capnography monitoring to confirm endotracheal tube (ETT) placement during elective intubation among patients in Emergency and critical care units of selected tertiary care hospital in Udupi district, Karnataka 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Athaullah S 
Designation  Post graduate student 
Affiliation  MCON,MAHE,Manipal 
Address  2nd year NPCC student MCON Manipal

Udupi
KARNATAKA
576104
India 
Phone  9965275836  
Fax    
Email  athaullahjain@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Anil Raj A 
Designation  Assistant Professor 
Affiliation  MCON,MAHE,Manipal 
Address  Department of Medical Surgical Nursing,MCON,MAHE,Manipal

Udupi
KARNATAKA
576104
India 
Phone  7411892986  
Fax    
Email  anil.raj@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Mr Anil Raj A 
Designation  Assistant Professor 
Affiliation  MCON,MAHE,Manipal 
Address  Department of Medical Surgical Nursing,MCON,MAHE,Manipal

Udupi
KARNATAKA
576104
India 
Phone  7411892986  
Fax    
Email  anil.raj@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Manipal College of Nursing, MAHE ,Manipal 
Address  Manipal College of Nursing, MAHE ,Manipal 
Type of Sponsor  Research institution 
 
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 Vimal Krishnan S  Kasturba Hospital  Room No:22 and 23,blue and red zone, Department of Emergency Medicine Kasturba Hospital, MAHE (Division) Manipal
Udupi
KARNATAKA 		 7907953224

vimal.krishnan@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients those requiring elective intubation in the emergency and critical care department.
 
 
ExclusionCriteria 
Details  Pregnancy,Females in the reproductive age group Emergency cases,Anatomical neck distortion due any cause (eg- surgery/ radiation therapy),Patients with subcutaneous emphysema, and pneumothorax
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Confirmation of ET Tube placement in time
 		 At baseline, during the intubation
 
 
Secondary Outcome  
Outcome  TimePoints 
Avoid Oesophageal intubation, Confirming endotracheal tube after intubation.
 		 at baseline, during the intubation
 
 
Target Sample Size   Total Sample Size="107"
Sample Size from India="107" 
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)   24/02/2023 
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="7"
Days="13" 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (NA).

  6. For how long will this data be available start date provided 01-05-2024 and end date provided 01-05-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Upon obtaining administrative permission and ethical committee clearance the data will be collected from the study participants who are meeting the inclusion and exclusion criteria. Whenever there is elective intubation happening in red zone of emergency medicine department and critical care medicine department of the selected hospital, the researcher will explain the study objectives to the patient and upon obtaining consent they will be enrolled in to the study. As the elective intubation is going on, the second physician will be performing the transtracheal sonography for confirming the ETT tube placement and the researcher will be notify the time duration from the initiation of intubation procedure. Later on, the wave form capnography also will be obtained from the same patient and notify the time taken from the initiation of intubation procedure. The average time duration of both techniques will be compared to determine the appropriate measure in confirming the ETT placement.

 
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