| CTRI Number |
CTRI/2024/03/063888 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
comparative study of TAScope Vs Kingvision in ease of intubation and haemodynamic changes |
|
Scientific Title of Study
|
A prospective randomized comparative study of TAScope Vs Kingvision in ease of intubation and haemodynamic changes |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asma Rahat |
| Designation |
Assistant professor |
| Affiliation |
Rohilkhand medical college |
| Address |
Department of Anaesthesia
Rohilkhand medical college Pilibhit Bypass Rd Pawan Vihar Bareilly Uttar Pradesh Rohilkhand medical college Pilibhit Bypass Rd Pawan Vihar Bareilly Uttar Pradesh Bareilly UTTAR PRADESH 243006 India |
| Phone |
9045160131 |
| Fax |
|
| Email |
asma11rahat.ar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Asma Rahat |
| Designation |
Assistant professor |
| Affiliation |
Rohilkhand medical college |
| Address |
Department of Anaesthesia
Rohilkhand medical college Pilibhit Bypass Rd Pawan Vihar Bareilly Uttar Pradesh Department of Anaesthesia
Rohilkhand medical college Pilibhit Bypass Rd Pawan Vihar Bareilly Uttar Pradesh Bareilly UTTAR PRADESH 243006 India |
| Phone |
9045160131 |
| Fax |
|
| Email |
asma11rahat.ar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Asma Rahat |
| Designation |
Assistant professor |
| Affiliation |
Rohilkhand medical college |
| Address |
Department of Anaesthesia
Rohilkhand medical college Pilibhit Bypass Rd Pawan Vihar Bareilly Uttar Pradesh Department of Anaesthesia
Rohilkhand medical college Pilibhit Bypass Rd Pawan Vihar Bareilly Uttar Pradesh Bareilly UTTAR PRADESH 243006 India |
| Phone |
9045160131 |
| Fax |
|
| Email |
asma11rahat.ar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesia ot complex
Rohilkhand medical college and hospital
Bareilly Uttar pradesh |
|
|
Primary Sponsor
|
| Name |
Department of anesthesia |
| Address |
Rohilkhand medical college Pilibhit Bypass Rd Pawan Vihar Bareilly Uttar Pradesh 243006 |
| Type of Sponsor |
Private 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 |
| Asma Rahat |
Rohilkhand medical college |
Room no 2060
Department of anesthesia
Rohilkhand medical college and hospital
Bareilly Bareilly UTTAR PRADESH |
9045160131
asma11rahat.ar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, RMCH, Bareilly,UP |
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 |
Kingsvision |
light weighted portable, selfcontained, battery operated video laryngoscope which is also water resistant. It has disposable blade which has a channel for Endotracheal tube insertion. It also has an anti-fogging mechanism |
| Intervention |
TAScope |
It utilizes boroscope camera(5.5 mm diameter HD camera) connectable to any laptop or even compatible mobiles or tablet, which becomes the screen for intubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective surgery with ASA grade 1 and 2, age between 20 to 65 years, all mallampati grades will be included in this study |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway or having any pathology of oral cavity which may obstruct insertion of device will be excluded from study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number of attempts.
2. Time for successful intubation.
3. Laryngoscopic view – POGO score(percentage of glottic opening)
4. Haemodynamic changes
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Airway trauma.
Post operative complications such as hoarseness of voice and sore throa |
1 year |
|
|
Target Sample Size
|
Total Sample Size="86" Sample Size from India="86"
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 1 |
|
Date of First Enrollment (India)
|
23/03/2024 |
| 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="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
|
Airway management is the assessment, planning and series of medical procedures required to maintain or restore an individual’s ventilation or oxygenation. A difficult airway is a situation in which a healthcare provider who can manage airway encounters difficulty with standard methods of airway management. Its definition is not standardised as there are some variations between national expert guidelines. The American Society of Anaesthesiologist (ASA) defines a difficult airway as existing when “a conventionally trained anaesthesiologist experiences difficulty with facemask ventilation of the upper airway, difficulty with tracheal intubation, or both.†King Vision is a light weighted portable, selfcontained, battery operated video laryngoscope which is also water resistant. It has disposable blade which has a channel for Endotracheal tube insertion. It also has an anti-fogging mechanism. TAScope (The Anaesthetist Society scope) is a video laryngoscope which aids in passing the tube in difficult airways. It utilizes boroscope camera(5.5 mm diameter HD camera) connectable to any laptop or even compatible mobiles or tablet, which becomes the screen for intubation. It also has a channel facilitating the insertion of bougie, on which endotracheal tube is railroaded over it under vision. It is useful for patients. |