| CTRI Number |
CTRI/2024/02/062397 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of non channeled King Vision vs Hugemed videolaryngoscope blades during tracheal intubation |
|
Scientific Title of Study
|
A RANDOMISED COMPARATIVE CLINICAL STUDY OF TRACHEAL INTUBATION WITH NON CHANNELED KING VISION VS HUGEMED VIDEOLARYNGOSCOPE BLADES |
| 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 DEEPA KATTISHETTAR |
| Designation |
Associate Professor |
| Affiliation |
Mysore Medical College, Mysore. |
| Address |
2nd floor, Department of Anaesthesiology, New stone building, K R Hospital, Mysore medical college and research institute, Irwin road, Mysrore
Mysore
KARNATAKA
570001
India |
| Phone |
9611104343 |
| Fax |
|
| Email |
deepapalax@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEEPA KATTISHETTAR |
| Designation |
Associate Professor |
| Affiliation |
Mysore Medical College, Mysore. |
| Address |
2nd floor, Department of Anaesthesiology, New stone building, K R Hospital, Mysore medical college and research institute, Irwin road, Mysrore
Mysore
KARNATAKA
570001
India |
| Phone |
9611104343 |
| Fax |
|
| Email |
deepapalax@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEEPA KATTISHETTAR |
| Designation |
Associate Professor |
| Affiliation |
Mysore Medical College, Mysore. |
| Address |
2nd floor, Department of Anaesthesiology, New stone building, K R Hospital, Mysore medical college and research institute, Irwin road, Mysrore
Mysore
KARNATAKA
570001
India |
| Phone |
9611104343 |
| Fax |
|
| Email |
deepapalax@gmail.com |
|
|
Source of Monetary or Material Support
|
| K R Hospital , Irwin road, Devaraja mohalla, yadavagiri, Mysore, Karnataka 570001 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology, MMCRI, Mysore |
| Address |
2nd floor, New stone building, K R Hospital, Mysore medical college and research institute, Mysore, Karnataka 570001 |
| Type of Sponsor |
Government 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 Aishwarya C |
K R HOSPITAL |
2nd floor, New stone building,Department of Anaesthesiology K R Hospital, Mysore medical college and research institute, Irwin road, Mysore 570001
Mysore
KARNATAKA |
9916547139
aishwaryabpl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE AND ASSOCIATED HOSPITALS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: H719||Unspecified cholesteatoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group Hugemed |
videolaryngoscopy before tracheal intubation in seconds |
| Comparator Agent |
Group KingVision |
Videolaryngoscopy before tracheal intubation in seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ALL ASA grade I and II patients
All modified mallampati class I and II patients |
|
| ExclusionCriteria |
| Details |
All ASA grade III and IV patients
Diabetes and hypertension
Pregnant and lactating women
Obesity (BMI >30 kg/m2)
Drug allergy
Hepatic and renal disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intubation time
Glottic view |
Baseline time in seconds at intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
First attempt & overall intubation success rate
External laryngeal manipulation like BURP to improve glottis view
Subjective degree of difficulty in intubation using five point likert scale |
Baseline after intubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a prospective randomised comparative clinical study of tracheal intubation with non channeled Kingvision vs Hugemed videolaryngoscope blades in patients under general anaesthesia in anticipated difficult airway to look for time for intubation and ease of intubation by trained anaesthesiologists in K R Hospital |