| CTRI Number |
CTRI/2020/04/024897 [Registered on: 28/04/2020] Trial Registered Prospectively |
| Last Modified On: |
27/04/2020 |
| 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 King Vision Video Laryngoscope With Macintosh Laryngoscope In Patients Having ANTICIPATED Difficult Airway |
|
Scientific Title of Study
|
Comparative Evaluation Of King Vision Video Laryngoscope And Macintosh Laryngoscope For Anticipated Difficult Endotracheal Intubation In Patients Undergoing Surgery Under General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rameez Raja |
| Designation |
Postgraduate Student |
| Affiliation |
ASCOMS HOSPITAL |
| Address |
Department of Anaesthesia ASCOMS Hospital Sidhra Jammu
Jammu
JAMMU & KASHMIR
180017
India |
| Phone |
9596434072 |
| Fax |
|
| Email |
rameez_raja36@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunana Gupta |
| Designation |
Associate Professor |
| Affiliation |
ASCOMS HOSPITAL |
| Address |
Department of Anaesthesia ASCOMS Hospital Sidhra Jammu
Jammu
JAMMU & KASHMIR
180017
India |
| Phone |
9419160705 |
| Fax |
|
| Email |
sunaynaarnav@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunana Gupta |
| Designation |
Associate Professor |
| Affiliation |
ASCOMS HOSPITAL |
| Address |
Department of Anaesthesia ASCOMS Hospital Sidhra Jammu
Jammu
JAMMU & KASHMIR
180017
India |
| Phone |
9419160705 |
| Fax |
|
| Email |
sunaynaarnav@yahoo.com |
|
|
Source of Monetary or Material Support
|
| ASCOMS Hospital Sidhra Jammu
180017 Jammu and Kashmir INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Rameez Raja |
| Address |
Department Of Anaesthesia ASCOMS hospital Sidhra Jammu |
| 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 Sunana Gupta |
ASCOMS HOSPITAL |
Department Of Anaesthesia 6th Floor ASCOMS Hospital Sidhra Jammu
Jammu
JAMMU & KASHMIR |
9419160705
sunaynaarnav@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Independent Ethics Committe ASCOMS Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No disease or Controlled Systemic Diseases |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
King Vision Video Laryngoscope |
video assisted Laryngoscope To Be Used For 1 year |
| Comparator Agent |
Macintosh Laryngoscope |
conventional Laryngoscope |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
•Patient Of Either Sex With ASA Grade I & II Plus Any One Or More Of The Following:
1.MPG Grade III & IV.
2.A Thyromental Distance <6 Cm.
3. Sterno Mental Distance <12 Cm.
4.Abnormal Upper Teeth: Loose Or Protruding Upper Teeth Or Partially Missing Upper Teeth Or Canines Or Wide Incisor Gap.
5.Impaired Temporomandibular Joint Mobility: Inter Incisor Gap< 38 Mm & Inability To Move The Lower Teeth In Front Of Upper Teeth ( Mandibular Protrusion Test Grade 2 Or Grade 3) Or Limited Mouth Opening.
6.Limited Neck Movements : Inability To Extend Or Flex Neck >90degree From Full Extension To Full Flexion.
7.History Of Difficult Laryngoscopy Or Intubation.
8.Body Mask Index (BMI) > 35kg/M2.
9.History Of Sleep Apnoea.
10.Neck Circumference > 40 Cm In Females & > 38 Cm In Males Measured At Thyroid Cartilage.
|
|
| ExclusionCriteria |
| Details |
•Age <20 Years Or >70 Years.
•ASA III And IV.
•MPG I And II.
•Patient With Any Contraindication To The Use Of Succinylcholine.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Success Rate Of Intubation In First Attempt By King Vision Video Laryngoscope |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number Of Intubation Attempts Required By King Vision Video Laryngoscope |
1 year |
|
|
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)
|
01/05/2020 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this prospective study, we propose to compare effictivness of Macintosh laryngoscope and King Vision video laryngoscope with respect to
success rate in first attempt, number of intubation attempts required, time to
intubation, Cormack-Lehane grading, hemodynamic response and the complications
related to layrngoscopy and intubation in patients with anticipated difficult endotracheal
intubation in 80 patients undegoing surgery under general anaesthesia. |