| CTRI Number |
CTRI/2022/07/043852 [Registered on: 08/07/2022] Trial Registered Prospectively |
| Last Modified On: |
29/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of video laryngoscope and direct laryngoscope in adult patient posted for surgeries under general anesthesia |
|
Scientific Title of Study
|
Comparison of king vision video laryngoscope and Macintosh laryngoscope in adult patients posted for surgeries under general anesthesia: A prospective randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAVIKUMAR K |
| Designation |
SECONDARY DNB RESIDENT |
| Affiliation |
SPARSH SUPER SPECIALTY HOSPITAL |
| Address |
SPARSH SUPER SPECIALTY HOSPITALS
#4/1 TUMKUR ROAD YESHWANTHPUR BANGALORE-560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9738780368 |
| Fax |
|
| Email |
RAVIKUMARK31@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR THIRUNAVUKKARASU SIVARAMAN |
| Designation |
Senior Consultant, Anaesthesia |
| Affiliation |
SPARSH SUPER SPECIALTY HOSPITAL |
| Address |
SPARSH SUPER SPECIALTY HOSPITALS
#4/1 TUMKUR ROAD YESHWANTHPUR BANGALORE-560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9731674319 |
| Fax |
|
| Email |
DRTHIRU.ANAES@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR THIRUNAVUKKARASU SIVARAMAN |
| Designation |
Senior Consultant, Anaesthesia |
| Affiliation |
SPARSH SUPER SPECIALTY HOSPITAL |
| Address |
SPARSH SUPER SPECIALTY HOSPITALS
#4/1 TUMKUR ROAD YESHWANTHPUR BANGALORE-560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9731674319 |
| Fax |
|
| Email |
DRTHIRU.ANAES@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SPARSH FOUNDATION |
| Address |
146, INFANTRY ROAD, OPP.POLICE COMMISSIONER OFFICE, BANGALORE 560001. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 RAVIKUMAR K |
SPARSH SUPER SPECIALTY HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY, OPERATION THEATRE COMPLEX,
SPARSH SUPER SPECIALTY HOSPITALS
#4/1 TUMKUR ROAD YESHWANTHPUR BANGALORE 560022
Bangalore
KARNATAKA |
9738780368
RAVIKUMARK31@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SPARSH HOSPITAL |
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 |
ENDOTRACHEAL INTUBATION |
ENDOTRACHEAL INTUBATION USING KING VISION VIDEO LARYNGOSCOPY |
| Comparator Agent |
ENDOTRACHEAL INTUBATION |
ENDOTRACHEAL INTUBATION WITH MACINTOSH DIRECT LARYNGOSCOPE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who give informed consent.
2. Adult patient of both the Genders
3. Age >18 years and <60 years
4. American Society of Anaesthesiologists physical status I to II
5. Modified Mallampati (Samsoon & Young) Airway class I and II
|
|
| ExclusionCriteria |
| Details |
1. Refusal by the patient to be part of the study.
2. Emergency surgeries
3. Risk of aspiration (non fasted, severe gastro-oesophageal disease, hiatal hernia)
4. Known or anticipated difficult airways (BMI > 35kg/m2, Modified Mallampati Airway > class III, Thyromental distance < 6cm, Inter incisor distance <3.5cm )
5. Known difficult mask ventilation, difficult laryngoscopy / scheduled for awake tracheal intubation
|
|
|
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 |
1. With respect to glottic (laryngoscopic) view (POGO score/ cormack lehane grading)
2. Time for successful intubation
3. Intubation success rate (number of attempts)
4. Difficult intubation score
|
Before and during intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Optimization maneuvers required to aid tracheal intubation,
2. Adverse events and technical problems
|
During and after intubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/07/2022 |
| 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 Applicable |
| 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 - NO
|
|
Brief Summary
|
•To evaluate and to compare the efficacy of King Vision video laryngoscope and Macintosh laryngoscope in adult patients posted for surgeries under general anesthesia with respect to glottic view (Cormack lehane grade & POGO Score) |