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CTRI Number  CTRI/2023/09/057251 [Registered on: 05/09/2023] Trial Registered Prospectively
Last Modified On: 24/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between two instruments which are used for putting tubes in air pipe of patients that helps in giving respiratory support in ICU patients 
Scientific Title of Study   A randomised control study to compare glottic view between Macintosh laryngoscope and King Vision Video laryngoscope in patients requiring endotracheal intubation in intensive care unit  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swetha B  
Designation  PG Resident Anaesthesiology 
Affiliation  MS Ramaiah Medical College 
Address  Postgraduate, Department of Anaesthesiology, M S Ramaiah Medical College, Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9902703847  
Fax    
Email  swethabasavaraj91@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinay R 
Designation  Assistant Professor 
Affiliation  M S Ramaiah Medical College 
Address  Department of Anaesthesiology, M S Ramaiah Medical College, Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9448883403  
Fax    
Email  vinayrangarajaiah@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinay R 
Designation  Assistant Professor 
Affiliation  M S Ramaiah Medical College 
Address  Department of Anaesthesiology, M S Ramaiah Medical College, Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9448883403  
Fax    
Email  vinayrangarajaiah@gmail.com  
 
Source of Monetary or Material Support  
M S Ramaiah Medical College, MSRIT Post, New BEL Road, Bangalore 560054 
 
Primary Sponsor  
Name  M S Ramaiah Medical College 
Address  New BEL Road, MSRIT Post, MSR Nagar, Bangalore 560040 
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 Vinay R  MS Ramaiah Medical College Hospital  Department of Anaesthesiology, Intensive Care Unit, Second Floor, M S Ramaiah Medical College Hospital, New BEL Road, MSRIT Post, MSR Nagar, Bangalore 560054
Bangalore
KARNATAKA 
9448883403

vinayrangarajaiah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MS Ramaiah Medical College 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  King Vision Video Laryngoscope  King Vision Video Laryngoscope will be used to assess the glottic view in ICU patients requiring endotracheal intubation 
Intervention  Macintosh Laryngoscope   Macintosh Laryngoscope will be used to assess the glottic view in ICU patients requiring endotracheal intubation  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Hemodynamically stable patients
 
 
ExclusionCriteria 
Details  Patient refusal
Pregnant woman
Limited mouth opening
Cervical spondylosis
Malformation of face
Airway tumors
Midline neck swelling
BMI >30kg/m2 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To compare the glottic view  To assess glottic view in terms of Cormack Lehane grading
Grade 1- full view of glottis
Grade 2- Partial view of glottis or aretynoids
Grade 3- only epiglottis visible
Grade 4- Neither glottis nor epiglottis visible 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To compare first attempt success rate of intubation & time taken for intubation  To assess first attempt success rate of intubation in terms of yes or no & time taken for intubation in seconds 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   11/09/2023 
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="7"
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 - NO
Brief Summary   Endotracheal intubation is the first step in any resuscitation to maintain patency of airway and if it is not secured well all the other lifesaving manoeuvres can fail. Direct laryngoscopy has been the standard technique for tracheal intubation for almost a century which requires aligning the pharyngeal, laryngeal and oral axes to achieve a line of sight. 
Airway management problems constitute 17% of anaesthesia closed claims, with difficult intubation being the most common at a rate of 5%. According to the American Society of Anaesthesiologists, the incidence of difficult intubation in the operating room is 1.2–3.8%; however, in emergency conditions, this rate is higher and reaches even 5.3%. Approximately 6% to 10% of patients undergoing surgical intervention are considered difficult laryngoscopy patients. The lack of first-pass success (FPS) in intubation has been associated with increased adverse events. Problems like delayed intubation, misplaced tracheal tube, or airway trauma are frequently encountered and can cause death or hypoxic brain damage. 
However over the last decades, technological advances have enabled the development of different devices for airway management. One such device is King Vision Video Laryngoscope (KVVL) which is used for management of normal and difficult airway. It is an indirect laryngoscope that provides view of glottis without alignment of oral, pharyngeal and tracheal axes. Limited studies are available for comparing the efficacy of Macintosh Laryngoscope and King Vision Video Laryngoscope for intubation in intensive care unit. 
Hence we aim at comparing the efficacy of Macintosh laryngoscope and King Vision Video laryngoscope for glottic view, first attempt success rate of intubation and time taken for intubation. 
 
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