| CTRI Number |
CTRI/2025/06/089221 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the effects of video laryngoscopy guided intubation on voice functions using fibreoptic, bougie and stylet as guides |
|
Scientific Title of Study
|
Comparing the effects of endotracheal intubation with video laryngoscope on vocal functions using video-assisted fibreoptic intubation (VAFI), bougie and stylet in adults undergoing general anaesthesia for elective surgeries; three-arm 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 |
Room No:2, 3rd floor Clinical Division, Department of Anaesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthal kuppam, Madagadipet,
Puducherry - 605 107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8072933145 |
| Fax |
|
| Email |
drkalaranjanik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ranjan RV |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Room No:4, 3rd floor Clinical Division, Department of Anaesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthal kuppam, Madagadipet,
Puducherry - 605 107
Pondicherry
PONDICHERRY
605107
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 |
Room No:2, 3rd floor Clinical Division, Department of Anaesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthal kuppam, Madagadipet,
Puducherry - 605 107
PONDICHERRY
605107
India |
| Phone |
8072933145 |
| Fax |
|
| Email |
drkalaranjanik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthal kuppam, Madagadipet,
Puducherry - 605 107 |
|
|
Primary Sponsor
|
| Name |
Kalaranjani K |
| Address |
Postgraduate, Department of Anaesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthal kuppam, Madagadipet, Puducherry - 605 107 |
| 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 |
| Dr Kalaranjani K |
Sri Manakula Vinayagar Medical College and Hospital |
Room No:2, 3rd floor Clinical Division, Department of Anaesthesiology, 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: J387||Other diseases of larynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bougie |
Under video laryngoscopic
guidance, bougie will be used for manoeuvring into the trachea, following which the endotracheal tube will be railroaded. |
| Comparator Agent |
Stylet |
Under video laryngoscopic
guidance, endotracheal tube will be preloaded with a stylet for manoeuvring into the trachea. |
| Intervention |
Video assisted fibreoptic intubation (VAFI) |
Under video laryngoscopic
guidance, fibreoptic scope will be used for manoeuvring into the trachea, following which the endotracheal tube will be railroaded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Modified Mallampati Grade less than 3
ASA PS 1 and 2
Anticipated duration of procedure less than 2 hours
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years
BMI more than 30 kg per m2
Modified Mallampati Grade more than 3
ASA PS more than 3
Duration of the procedure more than 2 hours
Emergency surgeries
Obstetric surgeries
ENT surgeries
Critically ill patients
Pre-existing voice disorders
Chronic smokers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Voice analysis measurements including fundamental frequency, jitter, shimmer, harmonic to noise ratio |
Before intubation and 24 hours after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of the impact of voice impairment using the Voice-Handicap Index (VHI) questionnaire |
24 hours after intubation |
| S/Z ratio and maximum phonation time (MPT) |
Before intubation and 2 hours after intubation |
| Intubation time |
From insertion of video laryngoscopy blade till appearance of EtCO2 curve |
| Number of intubation attempts |
From first time of insertion of guide till successful intubation |
| First-attempt success rates |
From first time of insertion of guide till successful intubation |
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
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)
|
23/06/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drkalaranjanik@gmail.com].
- For how long will this data be available start date provided 20-07-2026 and end date provided 20-07-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
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 which can result in injury to the larynx. This causes postoperative sore throat, hoarseness of voice and weakness of voice. 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 on voice complications 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 3 groups. After written informed consent, a voice sample will be collected for voice analysis. S/Z ratio and maximum phonation time will be measured. Standard institutional protocol for
general anaesthesia will be followed. Intubation will be done using video
laryngoscopy with VAFI, bougie or stylet as adjunct depending on the assigned
group. Efficacy of the adjuncts will be compared using time taken to
intubate, success at first attempt, and number of attempts at intubation. 24
hours postoperatively, voice sample will be collected for voice analysis.
Patient will be asked to fill out the Voice-Handicap Index (VHI) questionnaire.
S/Z ratio and maximum phonation time measurement will be repeated 24 hours
postoperatively.
Data will be collected during the study period of 12 months. Following this,
data analysis will be done to identify the superior method in terms of less voice complications, shorter intubation time, higher first attempt success rates, and lesser number of
attempts. This study would help in choosing a better guide for intubation
which could be extrapolated for avoiding vocal cord injury. Limitations of this
study include performer bias and need for assistant during the procedure. |