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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details   
 
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.

 
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