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CTRI Number  CTRI/2023/03/050393 [Registered on: 06/03/2023] Trial Registered Prospectively
Last Modified On: 01/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing 2 types of videolaryngoscopes to aid endotracheal intubation for surgeries under general anesthesia  
Scientific Title of Study   Comparison of King Vision Video Laryngoscpe with The Anaesthetist Society Scope(TASCOPE)for intubation in patients undergoing surgery under General Anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya MJ 
Designation  POST GRADUATE STUDENT 
Affiliation  SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCE  
Address  Department of Anaesthesiology Ground floor OT complex Sapthagiri institute of medical sciences & research centre No 15 Hesarghatta road Navy layout Chikkasandra

Bangalore
KARNATAKA
560090
India 
Phone  9481366992  
Fax    
Email  divyamj691@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Divya MJ 
Designation  POST GRADUATE STUDENT 
Affiliation  SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCE  
Address  Department of Anaesthesiology Ground floor OT complex Sapthagiri institute of medical sciences & research centre No 15 Hesarghatta road Navy layout Chikkasandra

Bangalore
KARNATAKA
560090
India 
Phone  9481366992  
Fax    
Email  divyamj691@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR RENUKA R 
Designation  PROFESSOR 
Affiliation  SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCE  
Address  Dept of Anesthesiology Ground floor OT complex Sapthagiri institute of medical science & research centre 15, Hesarghatta road Navy layout Chikkasandra

Bangalore
KARNATAKA
560090
India 
Phone  8105196837  
Fax    
Email  drmadhumitha99@gmail.com  
 
Source of Monetary or Material Support  
Sapthagiri institute of medical sciences and research centre 
 
Primary Sponsor  
Name  SAPTHGIRI INSTITUTE OF MEDICAL SCIENCE AND RESEARCH CENTRE 
Address  15 CHIKKASANDRA HESARAGHATTA MAIN ROAD BANGALORE 
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 
Divya MJ  Sapthagiri institute of medical sciences & research centre  OT complex Ground floor Department of anaesthesiology No 15 Chikkasandra Hesarghatta main road Bengaluru 560090
Bangalore
KARNATAKA 		 9481366992

divyamj691@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sapthagiri institute of medical sciences & research centre institutional ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K23||Disorders of esophagus in diseasesclassified elsewhere, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  King Vision Video Laryngoscope  Use of King Vision Video Laryngoscope as device to facilitate intubation during General anaesthesia.The insertion of this device takes few seconds only. As soon as this is inserted and glottis is visualised endotracheal tube is inserted into the trachea.Time taken for intubation and success rate in first attempt will be assesed.The whole procedure takes less than a minute time .Patient will be assesed for ten minutes after the procedure. 
Intervention  The Anaesthetist Society Scope(TASCOPE)  Use of TASCOPE as device to facilitate intubation during General anaesthesia.The insertion of this device takes few seconds only. As soon as this is inserted and glottis is visualised endotracheal tube is inserted into the trachea.Time taken for intubation and success rate in first attempt will be assesed.The whole procedure takes less than a minute time .Patient will be assesed for ten minutes after the procedure. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients willing to give written informed consent
2.ASA grade 1&2
3.Age 18 to 50 years
4.BMI of 18 to 24 kg/m2 
 
ExclusionCriteria 
Details  1.Patients who are not wiiling to participate in the study
2.Patients with difficult intubation & difficult mask ventilation
3.Patients with cervical instability
4.Pregnant females 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Asessment of ease of intubation and timetaken for intubation   from the time of insertion of blade to definitive EtCO2 graphic representation on the monitor which is usually 30-60 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
determine 1st attempt success rate  from the time of insertion of blade in 1st attempt till a definitive EtCO2 graphic representation on the monitor is obtained which is usually 30seconds -2 minutes 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   09/03/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report
    Response - None of the above

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [divyamj691@gmail.com].

  6. For how long will this data be available start date provided 30-12-2025 and end date provided 30-10-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a study comparing two  airway devices used for intubation in patients under General anesthesia.  The two devices used in this study have been designed with certain minute variations but serves the same purpose of being  highly beneficial in situations  of difficult airway, in patients with respiratory infections & in COVID 19 patients. The major difference among them  is their cost difference . Hence in  our study we  will be able to evaluate the efficacy and superiority of one device over the other . This will also enable us to asess their cost effectiveness.  If we find in our study the  indian model device to be safe  and effective then that can be the trendsetter and can be  utilised in future especially in resource limited settings and developing countries . 
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