| CTRI Number |
CTRI/2024/02/062425 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of a Camera-assisted Breathing-Tube Placement in the Patients Windpipe Before Anesthesia |
|
Scientific Title of Study
|
Awake Video-bronchoscopic Tracheal Intubation for Prevention of pulmonary Aspiration
associated with general anesthesia induction (AV-TIPA) - a clinical registry based
real-world-evidence study. |
| Trial Acronym |
AV-TIPA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Jyotirmay Kirtania |
| Designation |
Professor |
| Affiliation |
MPMMCC Tata Memorial Centre Varanasi |
| Address |
4th Floor OT Complex MPMMCC Tata Memorial Centre Varanasi
Sundarpur Varanasi Uttar Pradesh PIN 221005
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
05426917700 |
| Fax |
|
| Email |
jyotirmay@mpmmcc.tmc.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Jyotirmay Kirtania |
| Designation |
Professor |
| Affiliation |
MPMMCC Tata Memorial Centre Varanasi |
| Address |
4th Floor OT Complex MPMMCC Tata Memorial Centre Varanasi
Sundarpur Varanasi Uttar Pradesh PIN 221005
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
05426917700 |
| Fax |
|
| Email |
jyotirmay@mpmmcc.tmc.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nancy Saxena |
| Designation |
Junior Resident |
| Affiliation |
MPMMCC Tata Memorial Centre Varanasi |
| Address |
4th Floor OT Complex MPMMCC Tata Memorial Centre Varanasi
Sundarpur Varanasi Uttar Pradesh PIN 221005
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8317035734 |
| Fax |
|
| Email |
nan.csaxena@gmail.com |
|
|
Source of Monetary or Material Support
|
| MPMMCC Tata Memorial Center Varanasi |
|
|
Primary Sponsor
|
| Name |
MPMMCC Tata Memorial Centre Varanasi |
| Address |
MPMMCC Tata Memorial Centre Varanasi Sundarpur Varanasi Uttar
Pradesh PIN 221005 |
| Type of Sponsor |
Government 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 |
| Prof Jyotirmay Kirtania |
MPMMCC Tata Memorial Centre Varanasi |
Department of Anesthesia, 4th Floor OT Complex, MPMMCC Tata Memorial Centre Varanasi Sundarpur Varanasi Uttar Pradesh PIN 221005
Varanasi
UTTAR PRADESH |
05426917700
jyotirmay@mpmmcc.tmc.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, MPMMCC and HBCH Varanasi Mahamana Pandit Madan Mohan Malaviya Cancer Centre Sundar Bagiya, Near Nariya Gate Banaras Hindu University Campus Varanasi Varanasi Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients in the existing registry of awake tracheal intubation under topical anesthesia, performed by an attending doctor in the situation of pulmonary aspiration risk during general anesthesia for elective or emergency surgery. The procedure details recorded in the EMR of each such patient as a part of prevalent clinical practice, must match that in the clinical registry, for the case to be eligible for the study. |
|
| ExclusionCriteria |
| Details |
Any patient who underwent the same or similar procedure, but not appearing in the aforesaid clinical registry; or there is mismatched data or missing data. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Success rate and safety of video-bronchoscopic
awake tracheal intubation. |
Day 0 - Baseline (during the procedure)
Day 0 - Immediate postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The incidence of complications, & adverse events; types of devices used
for the procedure, & also the levels of experience of caregivers who performed and
supervised the procedures. |
1. Day 0, Baseline - At the time of awake tracheal intubation.
2. Day 0, Immediate postoperative - at the end of anesthesia procedure.
3. Postoperative day 1.
4. Day of discharge from hospital. |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/02/2024 |
| Date of Study Completion (India) |
12/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Imagine you or a loved one needs surgery under general anesthesia. During the procedure, a crucial step is placing a breathing tube into the windpipe to ensure you receive oxygen and can breathe safely throughout, till your recovery from general anesthesia. This process, called tracheal intubation, is the worldwide standard of care for major surgeries under general anesthesia. However, there’s a risk of stomach contents entering your lungs during
this process, which can be dangerous and life-threatening. Fasting before surgery greatly reduces this risk. However, even with proper fasting before surgery, many patients are still at risk due to various underlying diseases. Patients requiring emergency surgery with a full stomach face the same risk.
Our study aims to investigate a safer approach to tracheal intubation. We’re examining a method called video-bronchoscopic awake tracheal intubation. This technique involves using a small camera to guide tracheal tube placement while the patient is awake. Many anesthesiologists currently use this technique, but it’s not yet widely adopted for this scenario. By performing this procedure with the patient awake, under direct vision, without
sedation, and after numbing the throat with a local anesthetic solution, we can eliminate the risk of stomach contents entering the lungs during intubation. Conducting an experimental study to compare this technique with the conventional one would be ethically problematic.
We’ll analyze the real-world data of our Institute from past surgeries to measure the effectiveness, safety and feasibility of this approach in a medical team with diverse levels of experience. We shall assess any immediate or delayed complications recorded in the patient’s medical records related to the procedure or stomach contents entering the lungs under anesthesia.
While participants won’t directly benefit from this study of existing medical records, the insights gained will contribute to safer surgeries under general anesthesia for patients at risk of aspiration during tracheal intubation.
Patient privacy and confidentiality are our top priorities. Since we’re using existing medical records and not contacting patients for follow-up, we won’t need to obtain consent. We shall ensure that the information collected is used responsibly and securely, maintaining the privacy of patients’ clinical data. |