FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/092091 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison Of Video Laryngoscope And Conventional Laryngoscope For Endotracheal Intubation In Adults 
Scientific Title of Study   COMPARISON OF VIDEO LARYNGOSCOPE AND CONVENTIONAL LARYNGOSCOPE FOR ENDOTRACHEAL INTUBATION IN ADULTS WITH CERVICAL SPINE IMMOBILISATION 
Trial Acronym  Comparison Of Video Laryngoscope And Conventional Laryngoscope 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh MJ 
Designation  PG Resident 
Affiliation  Command Hospital (Air Force), Bengaluru 
Address  Dept. of Anaesthesiology, CH (AF), Bengaluru
room no -1 Dept. of Anaesthesiology Command Hospital (Air Force), Bengaluru - 560 007. Karnataka, India
Bangalore
KARNATAKA
560007
India 
Phone  9495162010  
Fax    
Email  maheshkhk99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gp Capt Dr Avanish Bhardwaj 
Designation  Professor 
Affiliation  Command Hospital (Air Force), Bengaluru 
Address  Professor Dept. of Anaesthesiology, CH (AF), Bengaluru.

Bangalore
KARNATAKA
560007
India 
Phone  9914734466  
Fax    
Email  avanishbhardwaj78@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gp Capt Dr Avanish Bhardwaj 
Designation  Professor 
Affiliation  Command Hospital (Air Force), Bengaluru 
Address  Professor Dept. of Anaesthesiology, CH (AF), Bengaluru.

Bangalore
KARNATAKA
560007
India 
Phone  9914734466  
Fax    
Email  avanishbhardwaj78@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesiology Command Hospital (Air Force), Bengaluru - 560 007. Karnataka, India 
 
Primary Sponsor  
Name  Dr Mahesh MJ 
Address  Dept. of Anaesthesiology Command Hospital (Air Force), Bengaluru - 560 007. Karnataka, India 
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 Mahesh MJ  command hospital airforce bangalore  Room No -1 Dept. of Anaesthesiology Command Hospital (Air Force), Bengaluru - 560 007. Karnataka, India.
Bangalore
KARNATAKA 
9495162010

maheshkhk99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Command Hospital Bangalore  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 
Intervention  Comparison Of Video Laryngoscope And Conventional Laryngoscope For Endotracheal Intubation In Adults With Cervical Spine Immobilisation  Adult Patients Aged 18 To 60 Years. Patients Classified As ASA Physical Status I And II. Patients Scheduled For Elective Endotracheal Intubation Under General Anaesthesia  
Comparator Agent  Comparison Of Video Laryngoscope And Conventional Laryngoscope For Endotracheal Intubation In Adults With Cervical Spine Immobilisation  Adult patients aged 18 to 60 years. Patients classified as ASA Physical Status I and II. Patients scheduled for elective endotracheal intubation under general anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients aged 18 to 60 years.
Patients classified as ASA Physical Status I and II.
Patients scheduled for elective endotracheal intubation under general anaesthesia
 
 
ExclusionCriteria 
Details  Patients with known severe airway deformity, restricted mouth opening, upper airway tumours, or anticipated difficult airway (Mallampati Class III & IV).
Patients who are on beta blockers or calcium channel blockers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluate the first-attempt success rate in seconds for endotracheal intubation between conventional
laryngoscope and video laryngoscope in patients with cervical spine immobilization.
 
Evaluate the first-attempt success rate in seconds for endotracheal intubation between conventional
laryngoscope and video laryngoscope in patients with cervical spine immobilization.
 
 
Secondary Outcome  
Outcome  TimePoints 
Determine the number of intubation attempts.
Measure the time taken for successful intubation.
Hemodynamic changes following laryngoscopy at 1, 3, & 5 minutes.
Requirement of Backward Upward Rightward Pressure (BURP) manoeuvre.
Record the use of adjuncts such as stylet or bougie during intubation.
Incidence of failed intubation & oesophageal intubation.
 
Determine the number of intubation attempts.
Measure the time taken for successful intubation.
Hemodynamic changes following laryngoscopy at 1, 3, & 5 minutes.
Requirement of Backward Upward Rightward Pressure (BURP) manoeuvre.
Record the use of adjuncts such as stylet or bougie during intubation.
Incidence of failed intubation & oesophageal intubation.
 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   15/08/2025 
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="6"
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
  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
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [maheshkhk99@gmail.com].

  6. For how long will this data be available start date provided 27-07-2025 and end date provided 27-07-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Study Design and Methodology

Participants
Adult patients aged 18 to 65 years undergoing elective surgery under general anaesthesia requiring endotracheal intubation will be enrolled provided they meet the inclusion criteria Informed written consent will be obtained from all participants prior to enrolment

Randomization
Patients will be randomly allocated into two groups using a computer generated randomisation table

  • Group V Video Laryngoscope Group

  • Group C Conventional Laryngoscope Group

Preoperative Assessment
All patients will undergo a thorough airway examination including

  • Mallampati grading

  • Mouth opening

  • Thyromental distance

  • Neck circumference

Relevant clinical history will also be recorded Standard preoperative fasting guidelines and ASA monitoring protocols will be followed

Anaesthetic Management
A standardized general anaesthesia protocol will be followed for both groups Monitoring will include

  • Electrocardiography ECG

  • Heart Rate HR

  • Oxygen Saturation SpO2

  • Non Invasive Blood Pressure NIBP cycled every 1 minute for 5 minutes post laryngoscopy and intubation

Baseline Parameters
Baseline values of Systolic Blood Pressure SBP Diastolic Blood Pressure DBP Mean Arterial Pressure MAP HR and SpO2 will be recorded

Induction Protocol

  • Injection Fentanyl 15 mcg per kg IV

  • Injection Propofol 1 to 2 mg per kg IV titrated to loss of verbal response

  • After confirming adequate ventilation Injection Vecuronium 01 mg per kg IV will be administered

  • Patients will be ventilated for 3 minutes with 100 percent oxygen and Sevoflurane 2 to 3 percent to achieve a MAC of 08 to 10

Airway Management
Cervical spine immobilization will be performed using manual inline stabilization MILS to prevent neck movement Patients will then be intubated using

  • Group V Video laryngoscope

  • Group C Conventional laryngoscope with an appropriate blade size

All intubations will be performed by experienced anaesthesiologists not residents The number of attempts for successful intubation will be recorded

Outcome Measures

Primary Outcome

  • Time to successful intubation from laryngoscope insertion to confirmation by five point auscultation or appearance of ETCO2 trace

Unsuccessful intubations will be recorded as failures for the respective group and these patients will be excluded from hemodynamic data analysis

Use of adjuncts such as stylet bougie and BURP manoeuvre will be documented

Secondary Outcomes
Hemodynamic parameters including HR SBP DBP and MAP will be recorded noninvasively at 1 3 and 5 minutes post laryngoscopy

Severe stress responses requiring pharmacological intervention will be noted

Adverse events such as

  • Desaturation SpO2 less than 93 percent

  • Failed or oesophageal intubation

  • Injuries to lips tongue teeth or oral cavity

  • Any other complications

will be recorded

Both groups will proceed with standard general anaesthesia protocols post intubation

 
Close