| CTRI Number |
CTRI/2024/05/068047 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To evaluate whether the customization of conventional flexitip laryngoscope by adding endoscopic camera improves the visualization of the airway in patients with normal airway imitated as difficult airway. |
|
Scientific Title of Study
|
Comparison of McCoy laryngoscope
with and without video assistance for
laryngoscopy and intubation in
patients with simulated difficult
airway. |
| 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
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
Rohtak
Haryana
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9034239374 |
| Fax |
|
| Email |
aggarwalteenu@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetan Kumar |
| Designation |
Junior Resident |
| Affiliation |
Pt B D Sharma , PGIMS , Rohtak |
| Address |
Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS, Rohtak
Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8581945772 |
| Fax |
|
| Email |
drchetan1414@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical care, Pt B D Sharma PGIMS, Rohtak, 124001, Haryana (India) |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt B D Sharma 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 Teena Bansal |
Pt B D Sharma PGIMS, Rohtak |
Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS ,Rohtak
Haryana ,India
124001
Rohtak
HARYANA |
9034239374
aggarwalteenu@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee, Pt. B. D. Sharma PGIMS/UHS, 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 |
1st Laryngoscopy with conventional McCoy laryngoscope and 2nd laryngoscopy with video assisted McCoy laryngoscope. |
1st Laryngoscopy will be done using conventional McCoy laryngoscope and glottis view, POGO score noted and 2nd laryngoscopy will be done in same patient after bag mask ventilation for 1 min with video assisted McCoy laryngoscope, glottis view and POGO score noted and intubation will be done in 2nd laryngoscopy.
One attempt for 1st laryngoscopy and one attempt for 2nd laryngoscopy will be allowed. On non visualization of glottis in 2nd laryngoscopy or duration more than 60 sec for tube insertion or desaturation SpO2 less than 94%, attempt will be considered a failure of intubation and alternative method to secure airway with collar removal will be done. |
| Intervention |
1st Laryngoscopy with video assisted McCoy laryngoscope and 2nd with video conventional McCoy laryngoscope. |
1st Laryngoscopy will be done using video assisted McCoy laryngoscope and glottis view, POGO score noted and 2nd laryngoscopy will be done in same patient after bag mask ventilation for 1 min with conventional McCoy laryngoscope, glottis view and POGO score noted and intubation will be done in 2nd laryngoscopy. One attempt for 1st laryngoscopy and one attempt for 2nd laryngoscopy will be allowed. On non visualization of glottis in 2nd laryngoscopy or duration more than 60 sec for tube insertion or desaturation SpO2 less than 94%, attempt will be considered a failure of intubation and alternative method to secure airway with collar removal will be done. |
|
|
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 Anesthesiologists status I or II
with normal airway. |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult
airway, body mass index more than 30kg per square meter
pregnancy, lactation, full stomach,
refusal to participate in the 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 |
To evaluate the improvement in Grade of glottic visualisation using modified Cormack-Lehane grade and percentage of glottic
opening (POGO). |
At the time of laryngoscopy after getting best glottic view within 30 seconds. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time for glottic visualisation (TG)
2. Time for tube insertion after glottic visualisation (TI)
3. Total intubation time (TT)
4. First attempt intubation success |
3 min after giving muscle relaxant, laryngoscopy will be done & different time taken will be noted |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2024 |
| 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 in simulated difficult airway using a self-assembled video laryngoscope will be done. Data will be compiled and analysed with appropriate statistical tests. |