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CTRI Number  CTRI/2024/09/074515 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 19/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Determining the depth of endotracheal tube insertion by using ultrasound  
Scientific Title of Study   Determining the correct insertion depth of tracheal tube by measuring distance between vocal cords and upper end of endotracheal tube cuff by using ultrasound:a cross sectional observational study 
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 ADITI RANA 
Designation  POST GRADUATE RESIDENT 
Affiliation  ESI-PGIMSR BASAIDARAPUR,NEW DELHI 
Address  Room number-2070,Department of Anaesthesiology and Critical Care,2nd floor,OT Complex,ESI Basaidarapur,Ring Road,New Delhi

West
DELHI
110015
India 
Phone  09818541198  
Fax    
Email  aditirana0307@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR PRASAD CGS 
Designation  H.O.D,Dept of Anaesthesiology and critical,Esi-Pgimsr Basaidarapur 
Affiliation  ESI-PGIMSR BASAIDARAPUR,NEW DELHI 
Address  Room number-2070,Department of Anaesthesiology and Critical Care,2nd floor,OT Complex,ESI Basaidarapur,Ring Road,New Delhi

West
DELHI
110015
India 
Phone  09480616548  
Fax    
Email  prasad_cgs@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR PRASAD CGS 
Designation  H.O.D,Dept of Anaesthesiology and critical,Esi-Pgimsr Basaidarapur 
Affiliation  ESI-PGIMSR BASAIDARAPUR,NEW DELHI 
Address  Room number-2070,Department of Anaesthesiology and Critical Care,2nd floor,OT Complex,ESI Basaidarapur,Ring Road,New Delhi

West
DELHI
DrAditi Rana
India 
Phone  09818541198  
Fax    
Email  aditirana0307@gmail.com  
 
Source of Monetary or Material Support  
ESI-Post Graduate Institute of Medical Sciences and Research,New Delhi-110015 
 
Primary Sponsor  
Name  ESI-Post Graduate Institute of Medical Sciences and Research,New Delhi-110015 
Address  Room no.2210,Dept.of anaesthesiology,2nd floor,OT Complex,ESI Basaidarapur,ring road,west delhi,delhi 
Type of Sponsor  Research institution and hospital 
 
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 
DrAditi Rana  ESI-Post Graduate Institute of Medical Sciences and Research,New Delhi-110015  Room no.2210,Dept.of anaesthesiology,2nd floor,OT Complex,ESI Basaidarapur,ring road,West Delfi,New Delhi,110015
West
DELHI 
09818541198

aditirana0307@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC ESI PGIMSR  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 
Intervention  Measuring distance between vocal cords and upper end of Endotracheal tube cuff using Ultrasound.  Determining the correct insertion depth of Tracheal tube by measuring distance between Vocal cords and upper end of Endotracheal tube cuff by Ultrasound after inflation of cuff with normal saline. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I & II
Patients posted for elective surgery with indication of orotracheal intubation 
 
ExclusionCriteria 
Details  Pateints with difficult airway
Patients with front of neck swellings
Patients with upper respiratory tract infections 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Measuring the distance of vocal cords from proximal margin of ETT cuff by Ultrasonography  Preoperative 
 
Secondary Outcome  
Outcome  TimePoints 
To note down the length of ET tube at the angle of mouth   Preoperative 
Time taken to identify vocal cords preoperatively  Preoperative 
Time taken to identify distance between vocal cords and proximal end of ETT cuff preoperatively  Preoperative 
 
Target Sample Size   Total Sample Size="73"
Sample Size from India="73" 
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)   01/10/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The aim of the study is to determine the correct insertion depth of tracheal tube by measuring distance between vocal cords and upper end of endotracheal tube cuff by ultrasound when the black marker on the endotracheal tube is placed just below the vocal cords.

Seventy three patients will be enrolled for the study.

Written informed consent will be taken from patients.

Patients will be selected according to the inclusion and exclusion criteria.

Preoperatively USG to identify vocal cords will be done and post intubation,ETT cuff will be inflated with saline and post intubation USG to identify distance between Vocal cords and Proximal end of ETT cuff will be done.

Primary objective is to measure the distance from the vocal cords to proximal end of ET tube by USG when the black marker on the endotracheal tube is placed just below the vocal cords.



 


 

 
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