| CTRI Number |
CTRI/2023/12/060913 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare best glottic view and partially restricted glottic view for intubation using self-assembled video-laryngoscope |
|
Scientific Title of Study
|
Comparison of best glottic view and partially restricted glottic view for orotracheal intubation using self assembled video-laryngoscope |
| 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 Teena Bansal |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9034239374 |
| Fax |
|
| Email |
aggarwalteenu@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Teena Bansal |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS, Rohtak
HARYANA
124001
India |
| Phone |
9034239374 |
| Fax |
|
| Email |
aggarwalteenu@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Teena Bansal |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS, Rohtak
HARYANA
124001
India |
| Phone |
9034239374 |
| Fax |
|
| Email |
aggarwalteenu@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Pt B D Sharma PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS |
| Address |
Department of Anaesthesiology and critical care, PGIMS, Rohtak, Haryana, 124001, INDIA |
| 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 Harsh Lakhanpal |
Pt B D Sharma PGIMS Rohtak |
Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS Rohtak.
Rohtak
HARYANA |
8073882878
lakhanpalharsh8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee, Pt B D Sharma PGIMS Rohtak |
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 |
orotracheal intubation using best glottic view |
self-assembled video laryngoscope will be introduced and blade will be placed close to the
larynx with its tip near the vallecula in an attempt to visualise the anterior commissure or as
much of the larynx as possible and best glottis view will be obtained. |
| Intervention |
orotracheal intubation using partially restricted glottic view |
first best glottis view will be obtained as in comparator group. Then blade will be moved
more proximally such that the blade tip and camera lens are positioned farther away from the
larynx and partially restricted glottic view will be obtained (Best glottic view will be restricted
to 50% or less for partially restricted glottic view). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex aged 18 to 65 years belonging to American Society of Anaesthesiologists status I or II scheduled for elective surgery under general anaesthesia requiring oro-tracheal intubation |
|
| ExclusionCriteria |
| Details |
Patients with:- 1.Anticipated difficult airway
2.body mass index >30Kg/m2
3.pregnancy or lactation
4.full stomach
5.refusal to participate in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total intubation time (Tt) in the two groups (best glottic view vs partially restricted glottic view) from insertion of laryngoscope into the mouth to insertion of tracheal tube into the trachea and confirmation with capnography |
At the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time for glottic visualization(Tg)
2.Grade of glottic visualization
3.Time for tube insertion after glottic visualization(Ti)
4.First attempt intubation success
5.Complications like cough, trauma & hoarseness of voice if any |
At time of intubation Tg, grade, Ti & first attempt success
Complication at extubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
09/01/2024 |
| 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="6"
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
|
The present prospective study will be conducted in department of anaesthesia and critical care, PGIMS, Rohtak. Written informed consent will be taken from patients included. Then comparison of best glottic view and partially restricted glottic view for intubation time using a self-assembled video laryngoscope will be done. Data will be compiled and analysed with appropriate statistical tests. |