| CTRI Number |
CTRI/2022/12/048314 [Registered on: 20/12/2022] Trial Registered Prospectively |
| Last Modified On: |
19/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasonography confirmation of endotracheal tube placement during general anaesthesia. |
|
Scientific Title of Study
|
Confirmation of endotracheal tube placement during general anaesthesia by ultrasonography. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR HARSHITHA K |
| Designation |
POST GRADUATE |
| Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL
KADUGONDANAHALLI
BANGALORE
Bangalore KARNATAKA 560045 India |
| Phone |
9591688648 |
| Fax |
|
| Email |
dr.harshithasunil@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR HARSOOR S S |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL
KADUGONDANAHALLI
BANGALORE
Bangalore KARNATAKA 560045 India |
| Phone |
9845279426 |
| Fax |
|
| Email |
harsoorss@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR HARSOOR S S |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL
KADUGONDANAHALLI
BANGALORE
KARNATAKA 560045 India |
| Phone |
9845279426 |
| Fax |
|
| Email |
harsoorss@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Dr Harshitha K |
| Address |
O.T COMPLEX, 1ST FLOOR
DEPARTMENT OF ANAESTHESIOLOGY
DR. B.R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL
KADUGONDANAHALLI, BANGALORE. 560045 |
| Type of Sponsor |
Other [] |
|
|
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 HARSHITHA K |
DR. B R Ambedkar medical college |
ROOM NO 1
O T COMPLEX DIVISION 1ST FLOOR
DEPARTMENT OF ANAESTHESIOLOGY
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL
KADUGONDANAHALLI BANGALORE 560045 Bangalore KARNATAKA |
9591688648
dr.harshithasunil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, (2) ICD-10 Condition: B||Imaging, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ULTRASONOGRAPHIC CONFIRMATION |
ULTRASONOGRAPHY CONFIRMATION OF ENDOTRACHEAL TUBE PLACEMENT DURING GENERAL ANAESTHESIA IN PATIENT UNDERGOING ELECTIVE SURGERY. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.ALL PATIENTS POSTED FOR ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA WITH ORO TRACHEAL INTUBATION.
2.PATIENTS BELONGING TO ASA - PS I AND II. |
|
| ExclusionCriteria |
| Details |
1.PATIENTS WITH KNOWN PREDICTORS OF DIFFICULT INTUBATION.
2. BMI MORE THAN 30KG/M2.
3. PREVIOUS HISTORY OF DIFFICULT INTUBATION. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO MEASURE THE TIME REQUIRED BY TANSTRACHEAL ULTRASONOGRAPHY TO CONFIRM THE ENDOTRACHEAL TUBE PLACEMENT. |
FROM THE TIME OF LARYNGOSCOPY TILL THE TIME OF APPEARANCE OF BULLET SIGN ON ULTRASONOGRAPHY. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DETERMINE THE RELIABILITY OF TRANSTRACHEAL ULTRASONOGRAPHY TO DETECT THE CORRECT PLACEMENT OF ENDOTRACHEAL TUBE. |
TO DETERMINE THE RELIABILITY OF TRANSTRACHEAL ULTRASONOGRAPHY TO DETECT THE CORRECT PLACEMENT OF ENDOTRACHEAL TUBE. |
|
|
Target Sample Size
|
Total Sample Size="160" Sample Size from India="160"
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)
|
22/12/2022 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The cornerstone of airway management and resuscitation of patients is ‘rapid and accurate endotracheal tube placement’. Securing a definitive airway in any setting as in operation theatre, intensive care unit (ICU), emergency department is always a necessary. Various methodologies like visualization of vocal cords during laryngoscopy followed by endotracheal tube placement, chest wall expansion following ventilation, visualization of tracheal rings and carina by bronchoscopy, chest auscultation, capnometry or capnography are available for confirmation of endotracheal tube placement. But there is no perfect modality for confirmation and very few methods are reliable. Constant non-availability of these modalities is a major drawback. The Advanced Cardiac Life Support (ACLS) 2015 guidelines recommend the usage of capnographic waveform along with clinical assessment for confirmation of endotracheal tube placement. Capnography is said to be the gold standard for confirmation which works on the principle of carbon dioxide detection, but has its own limitations like the availability in emergency departments and its dependency on adequacy of pulmonary blood flow makes it non reliable in conditions like pulmonary embolism, low cardiac output states, cardiac arrest (where cardiopulmonary resuscitation is not initiated/arrest for a prolonged period) and airway obstruction. False results have been noted when epinephrine was used. Ultrasonography is now emerging as a promising tool for rapid assessment of endotracheal tube placement. Ultrasound machine is portable, widely available, non-invasive, cost effective, easy reproducibility of images and has good safety record. Moreover, its available in all settings like emergency department, ICU and operation theatre. Confirmation of endotracheal tube in the trachea is confirmed by absence of “ Snow storm sign†(disturbance of tracheal air-mucosa interface with comet tail artefacts) visualized in ultrasound. Learning curve of transtracheal ultrasound has also been observed to be not difficult. Hence it can be used as a potential alternative to capnography during non-availability or when there is compromise in carbon dioxide detection by capnography. |