| CTRI Number |
CTRI/2024/03/064852 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross over study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing diagnostic accuracy of two different ultrasound guided methods to confirm the position of endotracheal tube in patients undergoing elective surgery |
|
Scientific Title of Study
|
A prospective observational study to assess the diagnostic accuracy of suprasternal versus subxiphoid ultrasonography for endotracheal intubation in patients undergoing elective surgery |
| 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 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
K G Halli, Bangalore
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
K G Halli, Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
8928351213 |
| Fax |
|
| Email |
drng2105@gmail.com |
|
Details of Contact Person Public 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
K G Halli, Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
8928351213 |
| Fax |
|
| Email |
drng2105@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar medical college and hospital Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Neha Gupta |
| Address |
Dr B R Ambedkar Medical College and hospital
K G Halli Bangalore
Bangalore |
| 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 Neha Gupta |
OT COMPLEX |
Dr B R Ambedkar medical college and hospital
K G Halli, Bangalore
560045 Bangalore KARNATAKA |
8928351213
drng2105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective surgery under general anaesthesia with endotracheal intubation.
Patients belonging to age between 18- 80 years of either gender.
Patients belonging to American Society of Anaesthesiologist’s physical status (ASA- PS) I and II patients.
|
|
| ExclusionCriteria |
| Details |
An abnormal airway anatomy
Unanticipated difficult intubation
BMI more than 30 kg/m2
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the diagnostic accuracy of ultrasonography using suprasternal approach by identifying the passage of ET tube through trachea and subxiphoid approach by observing the diaphragmatic movements after endotracheal intubation to confirm the correct placement of ET tube compared to capnography |
To compare the diagnostic accuracy of ultrasonography using suprasternal approach by identifying the passage of ET tube through trachea and subxiphoid approach by observing the diaphragmatic movements after endotracheal intubation to confirm the correct placement of ET tube compared to capnography |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
04/04/2024 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
|
Safe airway management is a
priority in clinical care. Endotracheal intubation is an essential skill in
operating rooms, emergency department and intensive care units to safely
secure a patient’s airway. Rapid confirmation of the correct ET tube
placement is also important as incorrect placement is associated with adverse
outcomes. Endotracheal intubation is associated
with incorrect or displaced tubing in 6% to 25% of case
The best approach to confirm correct
placement of ET tube is observation of tube passage through vocal cords,
followed by chest and epigastric auscultation. Although no single confirmation technique
is completely reliable, continuous waveform capnography, along with clinical
evaluation, has been recommended to detect expiratory CO2 as the most
reliable method for confirming correct tube placement. Methods used to confirm
ETT must have a sensitivity of 100% in order to properly identify the
esophageal intubation. In recent times,
limited number of studies have been performed to confirm the endotracheal
intubation by ultrasonography, where the placement of ET tube can be
indirectly assessed by observing the pleura or diaphragm movement. Ultrasound can be used
as a reliable method for confirmation, without any limitation
. This confirmation
technique can be learned and practiced easily to reduce the hypoxia duration
due to misplacement and prevent complications like aspiration.
|
The
present study is focused on assessing the diagnostic accuracy of the two
approaches of confirming the endotracheal intubation via ultrasonography ie, suprasternal
approach where the passage of the ET tube through the trachea is observed and
subxiphoid approach where diaphragmatic movements after endotracheal intubation
are observed
|