| CTRI Number |
CTRI/2025/03/082319 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to evaluate whether TAScope provide better glottic view during laryngoscopy as compared to McCoy laryngoscope in patients with normal airway imitated as difficult airway. |
|
Scientific Title of Study
|
Comparing learning curve of McCoy laryngoscope and TAScope for endotracheal intubation by 2nd year anaesthesia residents in 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 Kirti Kshetrapal |
| Designation |
Professor |
| Affiliation |
Department of anesthesiology and critical care, Pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of anesthesiology and critical care, Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9215650615 |
| Fax |
|
| Email |
kamalkirti47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirti Kshetrapal |
| Designation |
Professor |
| Affiliation |
Department of anesthesiology and critical care, Pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of anesthesiology and critical care, Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9215650615 |
| Fax |
|
| Email |
kamalkirti47@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Rani |
| Designation |
Junior Resident |
| Affiliation |
Department of anesthesiology and critical care, Pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of anesthesiology and critical care, Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
08168761259 |
| Fax |
|
| Email |
manibisyer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology and critical care, Pt. B.D. Sharma PGIMS Rohtak, Haryana, 124001, India |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of anesthesiology 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 Manisha Rani |
Pt B.D Sharma, PGIMS Rohtak |
Department of anesthesiology and critical care, Pt. B.D. Sharma PGIMS Rohtak, Haryana, 124001, India
Rohtak
HARYANA |
08168761259
manibisyer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research 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 |
seven 2nd year residents will perform 5 intubation each using McCoy laryngoscope. |
Each participant will be allowed to perform intubation on the anaesthetized patient under the close supervision of the attending anaesthesiologist. Each participant will intubate five anaesthetized patients with McCoy laryngoscope. Two attempts will be given for each intubation on an anaesthetized patient with semi rigid cervical collar in situ to mimic difficult airway. The intubation will be considered fail if the resident is not able to intubate the trachea in two attempts or saturation falls to less than 92% or which will require 120sec to be performed. |
| Intervention |
seven 2nd year residents will perform 5 intubation each using TAScope. |
Each participant will be allowed to perform intubation on the anaesthetized patient under the close supervision of the attending anaesthesiologist. Each participant will intubate five anaesthetized patients with TAScope. Two attempts will be given for each intubation on an anaesthetized patient with semi rigid cervical collar in situ to mimic difficult airway. The intubation will be considered fail if the resident is not able to intubate the trachea in two attempts or saturation falls to less than 92% or which will require 120sec to be performed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 to 55 years, belonging to American Society of Anaesthesiologists physical status I-II, Mallampati grade 1 or 2, thyromental distance more than 6cm, interincisor distance more than 3.5cm and who are scheduled for elective surgery under general anaesthesia and tracheal intubation will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with Mallampati grade 3 or 4, thyromental distance less than 6cm, interincisor distance less than 3.5cm, restricted neck movement, receding mandible, facial abnormalities, risk of regurgitation and aspiration (For example intestinal obstruction, hernia, intestinal perforation etc), chest wall deformity, anticipated difficult airway, known advanced cardiovascular diseases, obstructive sleep apnea and refusal to participate in the study. |
|
|
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 evaluate the time required for modified Cormack-Lehane grading, Percentage of glottic opening (POGO) score and intubation difficulty score (IDS). |
At the time of laryngoscopy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intubation time & successful placement of the tracheal tube. |
Time from insertion of blade in the oral cavity till the appearance of capnography. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This present, prospective, comparative study will be conducted in Department of Anaesthesiology
and Critical Care, Pt.BD. Sharma PGIMS, Rohtak.Fourteen
2nd year anaesthesia residents will be randomized into two groups, Group T
and Group M of seven residents each using opaque sealed envelope. Seventy
patients will be equally randomized into both the groups using computer
generated random number sequence. Each
resident will perform 5 intubations each.The study will
consist of three parts. Part 1 study will include a video demonstration
of the tracheal intubation technique using TAScope or McCoy laryngoscope. Part 2 will consist of
extensive manikin training (Laerdal Airway Management Trainer). Each resident
will do minimum of 5 intubations with the allocated device. The manikin
training will be considered complete when the resident will accomplish three successful
intubations in a row. In part 3 resident will be allowed
to perform intubation on the anaesthetized patient under the close supervision of the attending anaesthesiologist. Each participant will intubate
five anaesthetized patients with allocated laryngoscope , and data related to
intubation will be recorded by an independent observer.The primary
end points will be time required for modified CL grading, POGO score and
intubation difficulty score (IDS) for each device. The secondary end points to be checked
will be intubation time and successful
placement of the tracheal tube. The additional
end points will include the incidence of dental trauma,
number of optimization maneuvers required for intubation, arterial
oxygen saturation during
or after attempts,
other minor complications (trauma
to lip or oral mucosa and presence of blood on blade).
. |