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
|
|
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
|
|
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. |