| CTRI Number |
CTRI/2024/12/077684 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of difficult intubation prior to surgery and giving difficulty score during endotracheal intubation |
|
Scientific Title of Study
|
USE OF VIDEOLARYNGOSCOPY AND VIDIAC (VIDEOLARYNGOSCOPIC INTUBATION AND DIFFICULT AIRWAY CLASSIFICATION) SCORE FOR PREDICTING VIDEOLARYNGOSCOPE ASSISTED DIFFICULT INTUBATION IN PATIENTS - A PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thota Sridhar |
| Designation |
Post Graduate Resident |
| Affiliation |
Command Hospital(EC), kolkata |
| Address |
OT complex, 2nd floor,Command Hospital(Eastern command), New Alipore, Kolkata
Kolkata WEST BENGAL 700023 India |
| Phone |
09701566391 |
| Fax |
|
| Email |
thota.sridhar20@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepak Dwivedi |
| Designation |
Professor in Anaesthesiology and Critical care |
| Affiliation |
Command Hospital(EC),kolkata |
| Address |
OT complex 2nd floor, Command Hospital(Eastern Command), New Alipore, Kolkata
Kolkata WEST BENGAL 700027 India |
| Phone |
8195915566 |
| Fax |
|
| Email |
deepakdwivedi739@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepak Dwivedi |
| Designation |
Professor in Anaesthesiology and Critical care |
| Affiliation |
Command Hospital(EC),kolkata |
| Address |
Command Hospital(Eastern Command), New Alipore, Kolkata
Kolkata WEST BENGAL 700027 India |
| Phone |
8195915566 |
| Fax |
|
| Email |
deepakdwivedi739@gmail.com |
|
|
Source of Monetary or Material Support
|
| dept of Anesthesiology and critical care,Command Hospital(EC),New Alipore, Kolkata, West Bengal, India, Pin 700027 |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Dept of Anesthesiology, 2nd floor, OT complex, Command hospital,New alipore, Kolkata, West Bengal,700027 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Thota Sridhar |
Command Hospital(EC) |
Dept of Anaesthesiology, 2nd floor, Operation Theatre complex Kolkata WEST BENGAL |
9701566391
thota.sridhar20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Command hospital. kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U072||COVID 19 virus not identified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA status 1 to 3
SARI score more than or equal to 4 |
|
| ExclusionCriteria |
| Details |
Pregnant women
Patients in whom awake intubation is planned
SARI score less than 4 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate VIDIAC score attained during videolaryngoscopy with cormack lehane grade in detecting difficult intubations |
Baseline 4 weeks and 16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare VIDIAC score with Simplified Airway Risk Index score(SARI score) |
Baseline, 8 weeks & 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="96" Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
03/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
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
Modification(s)
|
Effective airway management is the cornerstone of perioperative patient safety. Difficult airway remains a common challenge for Anesthesiologists, Intensivists, Emergency physicians and Otolaryngologists. Treating patients with difficult airway following an airway management algorithm helps to reduce the incidence of airway-related complications. Anesthesiologists as well as a range of professionals should develop appropriate strategies according to their own experience, patient status, type of surgery and available airway devices to achieve reliable preoperative evaluation and effective intraoperative monitoring to maximize the degree of patient safety. This study is planned to evaluate the patient’s airway for assessing the difficulty associated with the intubation using videolaryngoscopy and establishing a VIDIAC score for labelling the cases of difficult intubation and hence enabling the concerned clinicians to have proper strategy during procedures in future in order to avoid complications and minimize morbidity.. |