| CTRI Number |
CTRI/2023/07/055809 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare the ease of intubation using left vs right handed laryngoscope. |
|
Scientific Title of Study
|
A Comparative Study of Laryngoscopic Views and blade to tooth distance obtained using Non-Dominant vs Dominant hand for Laryngoscopy for Patients undergoing surgery under General Anaesthesia- A One Year Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devyani Sharma |
| Designation |
post graduate student |
| Affiliation |
Jawaharlal Nehru medical college |
| Address |
Department of Anaesthesiology, Jawaharlal nehru medical college, belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
7505996411 |
| Fax |
|
| Email |
devyani.93@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrManjunath CPatil |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru medical college |
| Address |
Department of Anaesthesiology, Jawaharlal nehru medical college, belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
7505996411 |
| Fax |
|
| Email |
mcpatil52@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Devyani Sharma |
| Designation |
post graduate student |
| Affiliation |
Jawaharlal Nehru medical college |
| Address |
Department of Anaesthesiology, Jawaharlal nehru medical college, belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
7505996411 |
| Fax |
|
| Email |
devyani.93@outlook.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr.Prabhakar kore hospital , JNMC, Belagavi 590010 |
|
|
Primary Sponsor
|
| Name |
DEVYANI SHARMA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JNMC MEDICAL COLLEGE, NEHRU NAGAR, BELAGAVI |
| 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 Devyani Sharma |
KLE Dr.Prabhakar Kore Hospital and Research institutution |
2nd floor, Department of Anaesthesiology.
Belgaum
KARNATAKA |
7505996411
devyani.93@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL LEFT HANDED LARYNGOSCOPY |
USING LEFT HANDED LARYNGOSCOPIC BLADE AN ATTEMPT WILL BE MADE TO VISUALIZE THE VOCAL CORDS AND INTUBATE THE PATIENT |
| Intervention |
Ease of Intubation |
Ease of Intubation using
Cormack-Lehane grading, Blade to tooth distance & time taken to intubate will be studied.
the intubation shall be tried twice for maximum of 60 sec, failing which the sample shall be excluded from the study. |
| Comparator Agent |
RIGHT HANDED LARYNGOSCOPY |
USING RIGHT HANDED LARYNGOSCOPIC BLADE AN ATTEMPT WILL BE MADE TO VISUALIZE THE VOCAL CORDS AND INTUBATE THE PATIENT |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA I and II.
2)18 to 60 years.
3)Scheduled for surgery under GA with endotracheal intubation.
|
|
| ExclusionCriteria |
| Details |
1)Patients with cardiovascular diseases like IHD , Arrythmias.
2)Patients with cervical spine fractures or cervical spine instability.
3)Patients with history of gastroesophageal reflux
4)Patients with traumatic facial abnormalities.
5) Patients with dentures/edentulous
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare laryngoscopic views and blade to tooth distance on laryngoscopy with non dominant or dominant hand using respective laryngoscope blades in patients undergoing general anaesthesia. |
from the point of insertion of scope to confirmation of equal bilateral air entry in the lungs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To note the time required for endotracheal intubation on laryngoscopy with non-dominant or dominant hand using respective laryngoscopic blades in patients undergoing general anaesthesia. |
from the point of insertion of scope to confirmation of equal bilateral air entry in the lungs |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/08/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
CONVENTIONAL LARYNGOSCOPY AS A PART OF ENDOTRACHEAL INTUBATION IS AN IMPORTANT RESUSCITATIVE SKILL THAT REQUIRES GOOD COORDINATION AND MANEUVERING. WHILE MOST MEDICAL EQUIPMENTS ARE NOT DESIGNED BASED ON THE FACT WHICH HAND IS BEING USED TO PERFORM A PARTICULAR PROCEDURE, THE LARYNGOSCOPE IS MEANT TO BE USED WITH THE LEFT HAND OF THE PERSONNEL HANDLING IT. WITH MY STUDY I AIM TO PROVE THAT LEFT VS RIGHT-HANDED LARYNGOSCOPY USING RESPECTIVE BLADES PROVIDES EQUALLY GOOD LARYNGOSCOPIC VIEWS. |