| CTRI Number |
CTRI/2024/05/068190 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 methods of putting the patients to sleep with new technique using camera enabled viewing. |
|
Scientific Title of Study
|
Comparison of Fiberoptic intubation with video assisted fiberoptic intubation in predicted difficult airway: A randomised controlled trial |
| 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 Vishal Saxena |
| Designation |
Junior resident |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Department of Anaesthesia, PGIMER, Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
vishalsaxena2311@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Department of Anaesthesia, PGIMER, Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09855900171 |
| Fax |
|
| Email |
Jaindivya77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Department of Anaesthesia, PGIMER, Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160022
India |
| Phone |
09855900171 |
| Fax |
|
| Email |
Jaindivya77@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate institute of medical education and research, Chandigarh, India, 160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and research |
| Address |
Department of anaesthesia,
4th Floor
Nehru Hospital, sector 12, Chandigarh, India, 160012
Postgraduate institute of medical education and research |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Divya jain |
Postgraduate Institute of medical education and research |
OT Complex, 4th floor
Department of Anaesthesia,
PGIMER, Sector 12
Chandigarh
Chandigarh
CHANDIGARH |
09855900171
Jaindivya77@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
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 |
| Comparator Agent |
FOB Group |
Endotracheal intubation will be performed by Fiberoptic bronchoscope after 4 minutes of induction. |
| Intervention |
VAFI Group |
Endotracheal intubation will be performed by Fiberoptic bronchoscope and videolaryngoscope after 4 minutes of induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA status I and II in the age range of 18-65 years patients of either gender undergoing elective surgery requiring endotracheal intubation having at least 1 predictor of difficult intubation |
|
| ExclusionCriteria |
| Details |
Patient’s Refusal
mouth opening ( less than 22mm)
Bleeding Disorders
ASA Physical status 4 or higher
Patients planned for Awake FOB will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to intubation |
immediately after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Glottic view |
30 seconds after laryngoscopy |
| Success rate |
1 minute after intubation |
| hypoxemia |
1 minute after intubation |
| Hemodynamic changes |
o minute, 1 minute, 3 minute, 5 minute, 10 minute, 15 minute after intubation |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| 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 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
|
84 adult patients of ASA status I and II in the age range of 18-65 years patients of either gender undergoing elective surgery requiring endotracheal intubation having at least 1 predictor of difficult intubation will be enrolled.Time taken to perform tracheal intubation will be recorded as primary objective. First pass success rate, overall success rate, glottic visualization , intubation difficulty score, additional external maneuvers, hypoxemia defined as oxygen saturation less than 90%, hemodynamic changes and incidence of complications would be recorded as secondary objectives.
|