| CTRI Number |
CTRI/2025/02/080828 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The study comparing direct laryngoscopy (DL) and video laryngoscopy (VL) for tracheal intubation |
|
Scientific Title of Study
|
A comparative study between conventional direct laryngoscopy and video laryngoscopy with respect to different parameters affecting endotracheal intubation |
| 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 Pooja Mishra |
| Designation |
Post Graduatee Trainee |
| Affiliation |
Bankura Sammilani Medical College |
| Address |
Department of Anaesthesiology, Bankura Sammilani Medical College, Lokepur, Post office- Kenduadihi, Bankura, pin- 722102
West Bengal, India
Bankura
WEST BENGAL
722102
India |
| Phone |
9836378751 |
| Fax |
|
| Email |
drpoojam0694@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Debasish Saha |
| Designation |
Professor and Head of the department |
| Affiliation |
bankura sammilani medical college |
| Address |
Department of Anaesthesiology, Bankura Sammilani Medical College, Lokepur, Post office- Kenduadihi, Bankura, pin- 722102
West Bengal, India
Bankura
WEST BENGAL
722102
India |
| Phone |
9434100947 |
| Fax |
|
| Email |
drdebashishsaha1965@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Debarati Goswami |
| Designation |
Assistant Professor |
| Affiliation |
bankura sammilani medical college |
| Address |
Department of Anaesthesiology, Bankura Sammilani Medical College, Lokepur, Post office- Kenduadihi, Bankura, pin- 722102
West Bengal, India
Bankura
WEST BENGAL
722102
India |
| Phone |
8918516721 |
| Fax |
|
| Email |
debarati.goswami92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office to Principal, Department of Anaesthesiology, Bankura Sammilani Medical College, Lokepur, Post office- Kenduadihi, Bankura, pin- 722102
West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Bankura Sammilani Medical College |
| Address |
Department of Anaesthesiology, Bankura Sammilani Medical College, Lokepur, Post office- Kenduadihi, Bankura, pin- 722102
West Bengal, India |
| 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 Pooja Mishra |
Bankura Sammilani Medical College |
Department of Anaesthesiology, Bankura Sammilani Medical College, Lokepur, Post office- Kenduadihi, Bankura, pin- 722102
West Bengal, India
Bankura
WEST BENGAL |
9836378751
drpoojam0694@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Bankura Sammilani medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K810||Acute cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
to compare duration of tracheal intubation in direct and video laryngoscopy |
|
| ExclusionCriteria |
| Details |
Patients having Mallampati grade 3 or more.
BMI 30KG/M2 or above.
Limited neck extension
Thyromental distance less than 6 cm
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the duration of tracheal intubation between two groups. |
SECONDS TO MINUTE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to determine intubation difficulty score
|
EASY TO DIFFICULT |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/02/2025 |
| 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="3"
Days="7" |
|
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
|
This is a prospective observational cross-sectional study between direct laryngoscopy and video laryngoscopy. our objective is to compare duration of tracheal intubation, patients parameters, intubation difficulty score between two groups. The proposed study is conducted in the patients scheduled for elective surgery under general anaesthesia at Bankura Sammilani Medical College and Hospital, Bankura. Our research hypothesis is to find out video laryngoscopy is less time consuming or not. |