| CTRI Number |
CTRI/2025/12/098439 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two intubaing instruments namely TAScope and CMAC |
|
Scientific Title of Study
|
Comparison of TAScope with C MAC in ease of intubation and haemodynamic changes: A randomised controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarfaraz Ahmed |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital,Bareilly |
| Address |
Department of Anaesthesia
Rohilkhand medical college and hospital
Pilibhit bypass road
Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9027347787 |
| Fax |
|
| Email |
sarfaraz_ahm2000@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anamika Kumari |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand medical college and hospital,Bareilly |
| Address |
Department of Anaesthesiology
Rohilkhand medical college and hospital
Pilibhit bypass road
Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8209487251 |
| Fax |
|
| Email |
Nmkkmr40@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anamika Kumari |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand medical college and hospital,Bareilly |
| Address |
Department of Anaesthesiology
Rohilkhand medical college and hospital
Pilibhit bypass road
Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8209487251 |
| Fax |
|
| Email |
Nmkkmr40@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Anamika Kumar |
| Address |
79 Ac girls hostel
Rohilkhand medical college and hospital |
| Type of Sponsor |
Other [Self] |
|
|
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 Sarfaraz Ahmed |
Rohilkhand medical college and hospital |
Operation theatre
Bareilly
UTTAR PRADESH |
9027347787
sarfaraz_ahm2000@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee,RMCH,Bareilly,U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of TAScope with C MAC in ease of intubation and haemodynamic changes. |
This study is designed as a randomized controlled trial to compare the TAScope and C MAC videolaryngoscope in adult patients undergoing elective surgery under general anesthesia as very few studies exist on the subject
The study aims to evaluate the clinical efficacy and ease of use of the TAScope versus C MAC providing evidence to guide device selection and making informed decisions about the choice of videolaryngoscope particularly in low resource settings where cost effectiveness is a key factor |
| Comparator Agent |
Use of two methods of intubation namely via TAScope and C mac |
Intubation will be performed on the patients using these two methods and hemodynamic changes will be noted at 3 min 5 min till 30 minutes of intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 American society of Anesthesiologist grade 1 or 2
2 BMI less than 30 kg per meter square
3 Posted for elective surgery of different specialties
4 Mallampati grades 1 and 2
|
|
| ExclusionCriteria |
| Details |
1 Anticipated difficult airway Mallampati grades 3 and 4 or Thyromental distance less than 6cm and inter incisor distance less than 2 and a half cm History of difficult airway management in past
2 Any pathology of the oral cavity that may obstruct the insertion of the device
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare TAScope with C MAC in ease of intubation and haemodynamic change |
Heart rate systolic blood pressure diastolic blood pressure mean arterial blood pressure and arterial O2 saturation will be recorded after induction with either methods then immediately after intubation and after 1 minute 3 minutes 5 minutes and 10 minutes of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
25/12/2025 |
| 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
|
The study titled “Comparative study of TAScope with C-MAC in ease of intubation and haemodynamic changes: A Randomised Controlled Trial”is a prospective study comparing two videolaryngoscopes—TAScope (an indigenous, affordable device) and C-MAC (a standard high-end device)—in patients undergoing elective surgeries under general anesthesia. Sixty adult patients will be randomly assigned to two groups of thirty each. The study aims to evaluate and compare the ease of intubation and hemodynamic responses between the two devices, using parameters like number of intubation attempts, intubation time, intubation difficulty score, POGO score, airway trauma, and postoperative sore throat. Data will be analyzed using SPSS software, with significance at p < 0.05. The study seeks to determine if TAScope offers performance comparable to C-MAC while being more cost-effective for use in resource-limited settings.
|