| CTRI Number |
CTRI/2025/03/083411 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Lifeline of Emergency Care: Studying Airway Management |
|
Scientific Title of Study
|
Assessment of Definitive Airway Management Practices Among Emergency Physicians in a Tertiary Care Hospital in Northern India |
| 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 Devansh Goyal |
| Designation |
Junior Resident III |
| Affiliation |
King Georges Medical University, Lucknow |
| Address |
Office Room 1 - Department of Emergency Medicine, Ground Floor Trauma Center, KGMU, Shah Meena, University Chowk, Lucknow, 226003
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9630725614 |
| Fax |
|
| Email |
agrawalashwin1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof. Haider Abbas |
| Designation |
Professor and Head |
| Affiliation |
King Georges Medical University, Lucknow |
| Address |
Office Room 1 Department of Emergency Medicine Ground floor Trauma Center, KGMU, Shah Meena, University Chowk, Lucknow, 226003
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9335037686 |
| Fax |
|
| Email |
haiderkgmu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Devansh Goyal |
| Designation |
Junior Resident III |
| Affiliation |
King Georges Medical University, Lucknow |
| Address |
Office Room 1 Department of Emergency Medicine, Ground Floor Trauma Center, Shah Meena, University Chowk, Lucknow, 226003
Lucknow UTTAR PRADESH 226101 India |
| Phone |
9630725614 |
| Fax |
|
| Email |
agrawalashwin1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine, Trauma Center Ground Floor, King George Medical University, Shah Meena Road, Chowk, Lucknow, India 226003 |
|
|
Primary Sponsor
|
| Name |
King George Medical University |
| Address |
Shah Meena Road, Chowk, Lucknow 226003 |
| 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 |
| Dr Devansh Goyal |
Emergency Department, Trauma Center, King George Medical University |
Department of Emergency Medicine, King George Medical University, Shah Meena Road, Chowk Lucknow UTTAR PRADESH |
9630725614
agrawalashwin1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KGMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J962||Acute and chronic respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged greater than 18 years as on the date of enrollment.
2. Patients who provide consent.
3. Patient who requires endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
1. Patient aged less than 18 year as on the date of enrollment.
2. Patient for whom consent could not be obtained
3. Patient who require endotracheal intubation secondary to procedural sedation and not due to the disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the current practices of definitive airway management among emergency physicians.
|
at the end of the study - 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To record the demographic profile of the patients requiring airway management, along with pre intubation assessment of airway.
|
At the end of the study - 6 months |
To observe the common indications in patients undergoing intubation presenting to ED of this hospital.
|
At the end of the study - 6 months |
To observe common techniques & methods used for endotracheal intubation in the emergency room.
|
At the end of the study - 6 months |
To observe & tabulate various intra-procedural & post-procedural complications of intubations & factors relating to them.
|
At the end of the study - 6 months |
|
|
Target Sample Size
|
Total Sample Size="87" Sample Size from India="87"
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)
|
04/04/2025 |
| 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="0" 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
|
Effective definitive airway management is crucial in emergency care. This study aims to evaluate the current definitive airway management practices among emergency physicians in a tertiary care center of Northern India. The primary objective is to assess the first attempt success rate of endotracheal intubation. This is a prospective, single-center, observational cohort study. The study will be conducted in the Emergency Department of King George Medical University, a tertiary care center in Northern India. The study will include the patients of >18 years of age who require endotracheal intubation, the process will be observed and will be recorded in the standardized proforma along with the relevant patients details. Data will be analyzed to assess the airway management practices and identify the areas of improvement. This study will provide valuable insights into current airway management practices and inform strategies to optimize patient safety and improve the quality of emergency care. |