| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [maheshkhk99@gmail.com].
- 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.
- 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 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 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 All intubations will be performed by experienced anaesthesiologists not residents The number of attempts for successful intubation will be recorded Outcome Measures Primary Outcome 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 |