| CTRI Number |
CTRI/2024/12/078381 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of the diagnostic accuracy of ultrasonography and capnography for confirming endotracheal tube placement |
|
Scientific Title of Study
|
Comparison of diagnostic accuracy of ultrasonography against capnography for the confirmation of endotracheal tube placement using saline versus air forcuff inflation in adult patients undergoing surgery under general anaesthesia : A randomised controlled 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 |
Srinithi |
| Designation |
Junior resident |
| Affiliation |
AIIMS BATHINDA ,PUNJAB |
| Address |
Department of Anaesthesiology,All india institute of medical science Bathinda , Punjab
Bathinda
PUNJAB
151001
India |
| Phone |
9994056111 |
| Fax |
|
| Email |
srinithisridhar98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti sharma |
| Designation |
Associate professor |
| Affiliation |
AIIMS BATHINDA |
| Address |
Department of Anaesthesiology
AIIMS BATHINDA
PUNHJAB
Bathinda
PUNJAB
151001
India |
| Phone |
9968583915 |
| Fax |
|
| Email |
doctorjyotisharma@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti sharma |
| Designation |
Associate professor |
| Affiliation |
AIIMS BATHINDA |
| Address |
Department of Anaesthesiology
AIIMS BATHINDA
PUNHJAB
Bathinda
PUNJAB
151001
India |
| Phone |
9968583915 |
| Fax |
|
| Email |
doctorjyotisharma@yahoo.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences , Mandi Dabwali Road, Bathinda Punjab India -151001 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Jyoti sharma |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,BATHINDA |
Department of Anaesthesiology, All india institute of medical sciences
Bathinda
PUNJAB |
9968583915
doctorjyotisharma@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
INTUBATED PATIENT |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Endotracheal tube cuff will be inflated with air and this will be observed as a hyperechoic air-mucosal interface with reverberation artifacts
|
| Intervention |
Group B |
ETT cuff will be inflated with saline and identified as a hypoechoic, oval-shaped structure in ultrasound
the probe will be moved to the left lateral side of trachea to see the “double track sign†for esophageal intubation.
In case of oesophageal intubation, ETT will be removed and trachea will be reintubated.
Following the confirmation of endotracheal tube placement through ultrasound, the capnography waveform will be observed for seven waveforms to re-verify the successful endotracheal intubation. Bilateral air entry will be confirmed by auscultation of the chest before securing the endotracheal tube. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients between 18years to 65years of age.
American Society of Anaesthesiology physical status (ASA-PS) I, II and III
Scheduled for endotracheal intubation during elective surgery under General anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Patients not giving consent
Patients at risk of pulmonary aspiration
Anticipated difficult intubation
Airway abnormality
Parturient
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of diagnostic accuracy of ultrasonography in verifying endotracheal tube
placement using air versus saline for cuff inflation. |
post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time required for endotracheal tube placement confirmation by USG using either saline or
air for cuff inflation. |
post intubation |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
30/12/2024 |
| 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="6"
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
|
Patients will be kept nil per oral in accordance with standard ASA guidelines.The USG linear probe (6-13 MHz, SonoSite Edge II) will be placed over the suprasternal notch in a transverse orientation to acquire sono-anatomy of the airway before endotracheal tube placement. Another qualified anaesthesiologist will perform endotracheal intubation with an appropriately sized ETT. In group A endotracheal tube cuff will be inflated with air and this will be observed as a hyperechoic air-mucosal interface with reverberation artifacts (comet tail) posteriorly and snowstorm sign in ultrasound. In group B ETT cuff will be inflated with saline and identified as a hypoechoic, oval-shaped structure in ultrasound. Thereafter the probe will be moved to the left lateral side of trachea to see the “double track sign†for esophageal intubation . In case of oesophageal intubation, ETT will be removed and trachea will be reintubated .Following the confirmation of endotracheal tube placement through ultrasound, the capnography waveform will be observed for seven waveforms to re-verify the successful endotracheal intubation. Bilateral air entry will be confirmed by auscultation of the chest before securing the endotracheal tube. Stopwatch will be used to record the time elapsed between the insertion of the endotracheal tube (ETT) and the confirmation of correct endotracheal intubation by either ultrasound (USG). |