| CTRI Number |
CTRI/2024/03/064263 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the efficiency of a newer technique of intubation: Video-assisted fibreoptic intubation (VAFI) to classical bougie for intubation using video laryngoscope |
|
Scientific Title of Study
|
The efficacy of Video-Assisted Fibreoptic Intubation compared to bougie-directed tracheal intubation in adult patients undergoing video laryngoscopy for elective surgeries: a single-blinded randomized 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 |
Kalaranjani K |
| Designation |
PG student |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
No:25, 6th cross, Kurinji Nagar, Lawspet, Puducherry 605 008 Dr. Kalaranjani K, PG student, Department of Anaesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthal kuppam, Madagadipet,
Puducherry - 605 107 Pondicherry PONDICHERRY 605008 India |
| Phone |
8072933145 |
| Fax |
|
| Email |
drkalaranjanik@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Ranjan RV |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Dr. Ranjan RV, Professor, Department of Anaesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthal kuppam, Madagadipet,
Puducherry - 605 107
Pondicherry PONDICHERRY 605008 India |
| Phone |
9600823772 |
| Fax |
|
| Email |
ranjanrv2005@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kalaranjani K |
| Designation |
PG student |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
No:25, 6th cross, Kurinji Nagar, Lawspet, Puducherry 605 008 Dr. Kalaranjani K, PG student, Department of Anaesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthal kuppam, Madagadipet,
Puducherry - 605 107 Pondicherry PONDICHERRY 605008 India |
| Phone |
8072933145 |
| Fax |
|
| Email |
drkalaranjanik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College and Hospital, Department of Anaesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthal kuppam, Madagadipet,
Puducherry - 605 107 |
|
|
Primary Sponsor
|
| Name |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthal kuppam, Madagadipet,
Puducherry - 605 107 |
| Type of Sponsor |
Private 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 Kalaranjani K |
Sri Manakula Vinayagar Medical College and Hospital |
Room no:1, Department of Anaesthesiology, Hospital block, Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthal kuppam, Madagadipet,
Puducherry - 605 107 Pondicherry PONDICHERRY |
8072933145
drkalaranjanik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH - 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 |
Bougie guided tracheal intubation |
Romovac bougie will be used to manoeuvre the endotracheal tube using video laryngoscopy.
This intervention will be carried out after induction of general anaesthesia and outcome will be measured till 24 hours postoperatively.
Duration of this intervention will be for a period of 18 months or till the sample size of 108 is achieved. |
| Intervention |
Video-assisted fibreoptic intubation |
Fibreoptic scope, that is, Ambuscope, will be used to manoeuvre the endotracheal tube using video laryngoscopy.
This intervention will be carried out after induction of general anaesthesia and outcome will be measured till 24 hours postoperatively.
Duration of this intervention will be for a period of 18 months or till the sample size of 108 is achieved. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery under general anaesthesia
ASA PS I and II
BMI 18 – 30 kg/m2 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for successful intubation |
Time from insertion of video laryngoscope blade into the mouth till tube cuff insufflation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| First attempt tracheal intubation success or failure |
First attempt success or failure will be assessed at the time of insertion of VAFI or bougie into the trachea for the first time. |
| Number of attempts |
Number of attempts will be measured after successful intubation. |
| Airway injury |
One hour & twenty four hours postoperatively |
| Hemodynamic changes |
At the time of guide insertion, 1 minutes & 3 minutes after insertion |
|
|
Target Sample Size
|
Total Sample Size="108" Sample Size from India="108"
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 2 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
During
general anaesthesia for surgical procedures, patient’s breathing will be
maintained by fixing an endotracheal tube inside the airway, which will be visualized
using a laryngoscope. Video laryngoscope is one such instrument used for
intubating a difficult airway. Various adjuncts can be used as a guide to
locate the trachea like bougies and stylets. However, these adjuncts have the
disadvantage of limited mobility and flexibility. Video-assisted Fibreoptic
Intubation (VAFI) is a newer technique with combined use of fibreoptic scope
and video laryngoscope. Not much research is available on comparison these
methods in Indian population. This study compares the efficacy of VAFI compared
to bougie guided endotracheal intubation using video laryngoscopy.
All
patients undergoing general anaesthesia will be screened using inclusion
criteria like age>18 years, ASA PS 1-II, and normal BMI. Older patients,
emergency surgeries, critically ill and pregnant patients will be excluded from
the study. Participants will be blinded and divided into 2 groups. After
written informed consent, standard institutional protocol for general
anaesthesia will be followed. Intubation will be done using video laryngoscopy
with VAFI or bougie as adjunct depending on the assigned group. Efficacy of the
adjuncts will be compared using time taken to intubate, success at first
attempt, number of attempts at intubation, evidence of airway injury and
hemodynamic changes after the procedure.
Data
will be collected during the study period of 18 months. Following this, data
analysis will be done to identify the superior method in terms of shorter
intubation time, higher first attempt success rates, lesser number of attempts,
and lesser incidence of airway injury and hemodynamic variability. This study would
help in choosing a better guide for intubation which could be extrapolated for
use in difficult airways. Limitations of this study include performer bias and
need for assistant during the procedure. |