| CTRI Number |
CTRI/2022/10/046175 [Registered on: 04/10/2022] Trial Registered Prospectively |
| Last Modified On: |
04/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of upper airway ultrasonography with expired carbon dioxide levels for confirmation of endotracheal tube location for patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparison of upper airway ultrasonography with end tidal
capnography for confirmation of endotracheal tube placement in patients
requiring general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KEERTHANA SHIVAJI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Shri BM Patil medical college and hospital, BLDE University |
| Address |
NRI Hostel, room number: B13,Shri BM Patil medical college and hospital, Bangaramma Sajjan campus, BLDE university.
Bijapur
KARNATAKA
586103
India |
| Phone |
9500679140 |
| Fax |
|
| Email |
keerthii0496@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sridevi Mulimani |
| Designation |
Associate professor |
| Affiliation |
Shri BM Patil medical college and hospital, BLDE University |
| Address |
Department of Anesthesiology, Shri BM Patil Medical college and hospital, BLDE university
Bijapur
KARNATAKA
586103
India |
| Phone |
8790888666 |
| Fax |
|
| Email |
SrideviMulimani1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Keerthana Shivaji |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Shri BM Patil medical college and hospital, BLDE University |
| Address |
NRI Hostel, Room number:B13, Shri BM Patil Medical College and Hospital, BLDE University
Bijapur
KARNATAKA
586103
India |
| Phone |
9500679140 |
| Fax |
|
| Email |
keerthii0496@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Shri BM Patil medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Shri BM Patil Medical College and Hospital |
| Address |
Department of Anesthesiology, Shri BM Patil medical college and hospital, BLDE university, Vijayapura, Karnataka-586103 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Keerthana Shivaji |
Shri BM Patil Medical college and hospital |
Department of Anesthesiology, Shri BM Patil Medical college and hospital, BLDE university, Vijayapura, Karnataka-586103
Bijapur
KARNATAKA |
9500679140
keerthii0496@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI BMPATIL MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
End Tidal Capnography |
The first four traces of End tidal capnography is seen for the duration of 15 seconds |
| Comparator Agent |
Upper airway ultrasonography |
Linear probe is used for imaging in B-Mode for the duration of 15 seconds |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective surgeries under general anaesthesia
only 1st attempt is included
ASA 1 AND 2 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for the confirmation of endotracheal tube location by ultrasonography and end tidal capnography |
Immediately after intubation within 10 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of correct esophageal intubations identified by ultrasonography and End tidal capnography |
Immediately after intubation within 10 seconds |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/10/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study compares ultrasonography and End tidal capnography for the confirmation of endotracheal tube location immediately after intubation. Time taken and number of correct esophageal intubation identified by both is compared to establish the usage of faster confirmation techniques of endotracheal tube location. |