| CTRI Number |
CTRI/2025/02/081377 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomised study to compare the intervention endotracheal intubation with TAScope and Video-assisted McIntosh laryngoscope by experienced anaesthesiologist in simulated difficult airway. |
|
Scientific Title of Study
|
A comparative evaluation of TAScope ( The Anesthetist Society scope) and Video-assisted Macintosh laryngoscope for endotracheal intubation in simulated difficult airway: A randomized study. |
| 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 Shilpa Popli |
| Designation |
Associate Professor |
| Affiliation |
Pt. BD Sharma PGIMS Rohtak, Haryana |
| Address |
Department of Anaesthesiology and Critical Care. Pt. BD Sharma
PGIMS Rohtak, Haryana
Department of Anaesthesiology and Critical Care. Pt. BD Sharma
PGIMS Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7009878553 |
| Fax |
|
| Email |
shilpapopli89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Popli |
| Designation |
Associate Professor |
| Affiliation |
Pt. BD Sharma PGIMS Rohtak, Haryana |
| Address |
Department of Anaesthesiology and Critical Care. Pt. BD Sharma
PGIMS Rohtak, Haryana
HARYANA
124001
India |
| Phone |
7009878553 |
| Fax |
|
| Email |
shilpapopli89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Popli |
| Designation |
Associate Professor |
| Affiliation |
Pt. BD Sharma PGIMS Rohtak, Haryana |
| Address |
Department of Anaesthesiology and Critical Care. Pt. BD Sharma
PGIMS Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7009878553 |
| Fax |
|
| Email |
shilpapopli89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care. Pt. BD Sharma
PGIMS Rohtak, Haryana |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Shilpa Popli |
PGIMS Rohtak |
Modular ot complex, 3rd floor, Department of Anaesthesiology and Critical Care. Pt. BD Sharma
PGIMS Rohtak
Rohtak
HARYANA |
7009878553
shilpapopli89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intubation |
Intubation will be done by Video-assisted Macintosh laryngoscope and hemodynamic monitoring will be recorded immediately and later at 2,4,6,8 and 10 minutes |
| Intervention |
Intubation |
Intubation will be done by TAScope videolaryngoscop and hemodynamic monitoring will be recorded immediately and later at 2,4,6,8 and 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged between 18-60 years of either sex, belonging
to American Society of Anesthesiologists (ASA) physical status I or II scheduled for
elective surgery requiring general anaesthesia and intubation will be enrolled in the
study. |
|
| ExclusionCriteria |
| Details |
Patients having respiratory or pharyngeal pathology, restricted
mouth opening, cervical spine injury, restricted cervical spine mobility, Rheumatoid
Arthritis, anticipated difficult intubation, aspiration risk, pregnancy, BMI > 30kgm -2
will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare intubation difficulty scale (IDS) score, rate of
successful intubation using TAScope and Indigenous MacIntosh videolaryngoscope in
simulated difficult airway |
Hemodynamic monitoring will be recorded immediately and later at 2,4,6,8 and 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time of intubation, CL grade, POGO score of
glottic view & hemodyamic parameters using TAScope & Indigenous MacIntosh
videolaryngoscope in simulated difficult airway. |
Hemodynamic monitoring will be recorded immediately & later at 2,4,6,8 & 10 minutes |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
10/03/2025 |
| 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="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 purpose of the study is the comparative evaluation of TAScope and video-assisted McIntosh laryngoscope for endotracheal intubation in simulated difficult airway. Videolaryngoscopes make the learning process easy as they do not require alignment of oral, pharyngeal, tracheal axis and also provide a magnified view. Both TAScope and Video-assisted McIntosh are indigenously developed with use of endoscopic cameras. The difference being the angulation provided in TAScope for better Glottic visualisation. The idea of the study is to evaluate whether there is role of angulation of blade in videolaryngoscopes and which amongst these devices can prove to be a better, safer and economical option for securing an airway during anticipated and unanticipated intubation. AIM- To compare TAScope and video-assisted McIntosh laryngoscope for endotracheal intubation in simulated difficult airway. PRIMARY OBJECTIVE- To compare intubation difficulty scale (IDS) score, rate of successful intubation using TAScope and Indigenous MacIntosh videolaryngoscope in simulated difficult airway SECONDARY OBJECTIVE- To compare the time of intubation, CL grade, POGO score of glottic view and hemodyamic parameters using TAScope and Indigenous MacIntosh videolaryngoscope in simulated difficult airway. |