| 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
|
|
|
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
|
|
|
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.
|