| CTRI Number |
CTRI/2023/11/059826 [Registered on: 14/11/2023] Trial Registered Prospectively |
| Last Modified On: |
24/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison between two methods of confirmation of endotracheal tube position among patients undergoing operations under general anaesthesia |
|
Scientific Title of Study
|
Comparative study between ultrasonography and capnography for ascertaining placement of endotracheal tube in patients undergoing general anaesthesia in a medical college of Kolkata |
| 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 Swati Lahiri |
| Designation |
Assistant Professor |
| Affiliation |
Medical college, Kolkata |
| Address |
Department - Anaesthesiology
Division - Green Building
Room - 3rd floor, room number - 1
88 College Street
Kolkata - 700073
West Bengal, India
Kolkata
WEST BENGAL
700073
India |
| Phone |
9836979351 |
| Fax |
|
| Email |
drslahiri11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Lahiri |
| Designation |
Assistant Professor |
| Affiliation |
Medical college, Kolkata |
| Address |
Department - Anaesthesiology
Division - Green Building
Room - 3rd floor, room number - 1
88 College Street
Kolkata - 700073
West Bengal, India
WEST BENGAL
700073
India |
| Phone |
9836979351 |
| Fax |
|
| Email |
drslahiri11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Lahiri |
| Designation |
Assistant Professor |
| Affiliation |
Medical college, Kolkata |
| Address |
Department - Anaesthesiology
Division - Green Building
Room - 3rd floor, room number - 1
88 College Street
Kolkata - 700073
West Bengal, India
WEST BENGAL
700073
India |
| Phone |
9836979351 |
| Fax |
|
| Email |
drslahiri11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Concerned authority, Medical College, Kolkata |
|
|
Primary Sponsor
|
| Name |
Dr Swati Lahiri |
| Address |
Om Tower, Flat 5A
36 C, B. T. Road
Kolkata - 700002 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Asim Kumar Kundu |
4/1, Rajkumar Chatterjee Road, Kolkata - 700037 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swati Lahiri |
Medical College, Kolkata |
Department - Anaesthesiology
Division - Green Building
Room - 3rd floor, room number 1
88 College street, Kolkata - 700073
West Bengal, India
Kolkata
WEST BENGAL |
9836979351
drslahiri11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MEDICAL COLLEGE, KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Confirmation of tube positioning by capnography |
Immediately after endotracheal intubation, capnography sampling line will be connected to endotracheal tube and capnography waves observed to confirm tube positioning, in the same group of patients as that in intervention arm. |
| Intervention |
Confirmation of tube positioning by ultrasonography |
Immediately after endotracheal intubation, airway ultrasonography will be done to confirm tube position. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will require intubation for general anaesthesia during elective surgery with ASA-PS I, II & III |
|
| ExclusionCriteria |
| Details |
1. Patients with anatomical neck distortion
2. Patients with ASA grade IV, V
3. Patients with limited neck extension
4. Patients with history of difficult tracheal intubation
5. Patients with abnormal airway anatomy
6. Patients with high risk of aspiration
7. Patients with severe cardiac, pulmonary, hepatic, renal or coagulative disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of ultrasonography technique with respect to their efficacy to detect proper endotracheal position of endotracheal tube compared to end tidal capnography |
Single observation at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feasibility of ultrasonography to detect accidental esophageal intubation. |
Single observation at the baseline. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
04/12/2023 |
| 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="4"
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
|
Patients who will require intubation for general anaesthesia during elective surgery with ASA-PS I, II & III status will be included in our study. After endotracheal intubation, Proper tube position in each patient will be detected by both ultrasonography and capnography method. Time taken by each diagnostic method will be recorded. Time counting will start when the intubator will announce the visualization of the vocal cord, with both screens of ultrasound monitor and the capnography will face opposite to each other, so that the observer will not be able to see them. Ultrasound probe will be placed transversely over the suprasternal notch initially & moved cephalad for tracheal imaging and then placed over right upper quadrant of abdomen below the rib cage for diaphragmetic view. The capnography sampling line will be connected to the endotracheal tube and observed for capnography waves. Efficacy and time taken by ultrasonography to detect proper tube positioning will be compared with that of capnography. |