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CTRI Number  CTRI/2023/09/057808 [Registered on: 18/09/2023] Trial Registered Prospectively
Last Modified On: 18/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Comparative observational study 
Study Design  Other 
Public Title of Study   Comparison of videolaryngoscope and macintosh laryngoscope in routine intubation in adult patients 
Scientific Title of Study   A comparative study of king vision video laryngoscope with macintosh laryngoscope in adult patients for routine intubation  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahitha yanamadala 
Designation  Doctor 
Affiliation  Kasturba medical college mangalore  
Address  Postgraduate Department of anaesthesiology Light house hill road Kasturba medical college Mangalore Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9492567073  
Fax    
Email  mahithayanamadala123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suresh YV 
Designation  Doctor 
Affiliation  Kasturba medical college mangalore  
Address  Professor Department of anaesthesiology Kasturba medical college Lighthouse hill road Mangalore Dakshana Kannada Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9845085108  
Fax    
Email  sureshyv63@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mahitha yanamadala 
Designation  Doctor 
Affiliation  Kasturba medical college mangalore  
Address  Postgraduate Department of anaesthesiology Kasturba medical college Lighthouse hill road Mangalore Dakshana Kannada Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9492567073  
Fax    
Email  mahithayanamadala123@gmail.com  
 
Source of Monetary or Material Support  
Kasturba medical college ,mangalore wenlock district hospital KMC, Attavar, mangalore Dhakshinakannada Karnataka Pin: 575001 
 
Primary Sponsor  
Name  Dr Mahitha Yanamadala 
Address  Postgraduate, Department of anaesthesiology Kasturba medical college lighthouse hill road dakshina kannada karnataka 575003 Mangalore  
Type of Sponsor  Other [Self] 
 
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 Mahitha yanamadala  Kasturba medical college hospitals   Department of Anaesthesiology Kasturba medical college Lighthouse hill road Mangalore Dakshana Kannada Karnataka 575001
Dakshina Kannada
KARNATAKA 		 9492567073

mahithayanamadala123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicsCommitteeKasturbaMedicalCollegemangalore  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  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing elective surgeries under general anaesthesia
Patients of ASA 1 and ASA 2
Mallampatti Grade 1 to 3 
 
ExclusionCriteria 
Details  Anticipated difficult airway (Mallampatti grade 4, mouth opening less than 2 finger breadth , BMI >30kg/m2
Patients needing emergency surgeries will be excluded
Pregnancy and lactation 
 
Method of Generating Random Sequence   Other 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Best glottic view(cormack Lehane grading achieved)
Time taken for intubation
 		 1.Best glottic view(cormack Lehane grading achieved)-immeadiatley after laryngoscopy
2.Time taken for intubation (time from when the laryngoscope enters the inter-incisor area to visual conformation of the tube entering the glottis) 
 
Secondary Outcome  
Outcome  TimePoints 
Heart rate
Systolic blood pressure
Diastolic blood pressure
Peripheral oxygen saturation
 		 Before Induction
Before Laryngoscopy
Immediately after intubation
3minutes after intubation
Time taken to intubate
 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   02/10/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mahithayanamadala123@gmail.com].

  6. For how long will this data be available start date provided 30-01-2023 and end date provided 31-01-2024?
    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  

Unanticipated difficult laryngoscopy incidence is 1 -8.5%9. Though difficult airway guidelines including DAS 2015 recommend video laryngoscope as first choice for routine intubation 10. Their use is limited to patients with anticipated difficult airway. We believe routine video laryngoscope intubation will improve glottic view helping in successful intubation and with proper practice will reduce time of intubation and complications. 

 Hence video laryngoscopes should be a part of routine intubations and all anaesthesiologist’s should be trained to use video laryngoscope for routine intubations.

 
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