| CTRI Number |
CTRI/2024/02/063059 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of different types of laryngoscopes for airway management during general Anaesthesia |
|
Scientific Title of Study
|
Comparison of TAS(The Anesthesiologist Society) video laryngoscope and McCoy laryngoscope for orotracheal intubation: A randomized control 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 |
Dr Sangamesh Nainegali |
| Designation |
Professor of Anesthesiology |
| Affiliation |
SNMC AND HSK HOSPITAL NAVANGAR BAGALKOT |
| Address |
S Nijalingappa Medical college and HSK hospital
S Nijalingappa Medical college and HSK hospital
Bagalkot
KARNATAKA
587102
India |
| Phone |
9845268463 |
| Fax |
|
| Email |
ndrsangamesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangamesh Nainegali |
| Designation |
Professor of Anesthesiology |
| Affiliation |
SNMC AND HSK HOSPITAL NAVANGAR BAGALKOT |
| Address |
S Nijalingappa Medical college and HSK hospital
S Nijalingappa Medical college and HSK hospital
Bagalkot
KARNATAKA
587102
India |
| Phone |
9845268463 |
| Fax |
|
| Email |
ndrsangamesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Priya |
| Designation |
First year Anaesthesia PG |
| Affiliation |
S Nijalingappa Medical college and HSK hospital |
| Address |
Room no 85
Snmc girls pg hostel
Snmc
Room no 85
Snmc girls pg hostel
Snmc
Bagalkot
KARNATAKA
587102
India |
| Phone |
7042647110 |
| Fax |
|
| Email |
akankshapriya37@gmail.com |
|
|
Source of Monetary or Material Support
|
| S N Medical college and HSk hospital Bagalkot |
|
|
Primary Sponsor
|
| Name |
SNMC AND HSK HOSPITAL NAVANAGAR BAGALKOT |
| Address |
First floor Major OT complex SNMC AND HSK HOSPITAL Navanagar BAGALKOT |
| 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 |
| Dr Sangamesh Nainegali |
SNMC and HSK hospital |
Major ot complex SNMC hospital and HSK hospital
Bangalore
KARNATAKA |
9845268463
ndrsangamesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC institutional ethics committee of Human Research |
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 |
Mc coy laryngoscope |
Mc coy laryngoscope for orotracheal intubation for patients undergoing elective surgery under general anaesthesia |
| Intervention |
TAS(The Anaesthetic Scope) |
using TAS for orotracheal intubation in patient undergoing elective surgery under general anaesthesia to reduce hemodynamic response and less intubation difficulty score |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
o ASA physical status I and II
o Age between 18 to 60 years
o Body mass index of 18-35kg m2
o Patients having MPC 1,2,3
|
|
| ExclusionCriteria |
| Details |
Patient with hemodynamic and respiratory compromise.
Anticipated difficult airway.
History of gastroesophageal reflux disease.
Patient having cervical spine instability.
Patient having BMI more than 35. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
INTUBATION DIFFICULTY SCORE Combination of number of attempts , operators cormack
lehane grading , lifting force applied ,laryngeal pressure applied. |
Scoring will be given from 1 to 7 which will decide intubation difficulty
Score 0 - easy intubation
Score (1-5) -sligh difficult intubation
5-moderate to major difficulty
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
: To compare the following parameters between the TAScope & McCoy laryngoscope
i. Intubation success
ii. Intubation Time
iii. Hemodynamics
iv. Complications |
10 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/02/2024 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ndrsangamesh@gmail.com].
- For how long will this data be available start date provided 16-07-2025 and end date provided 17-10-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Airway catastrophe is still one of the leading causes of mortality and morbidity in anaesthesia. Various steps have been made to modify laryngoscope from the traditional Macintosh to the digital video laryngoscope to improve the success of intubation . McCoy is an upgraded version of Macintosh which provides better visualization of glottis and less force to be applied thereby attenuating the stress response for intubation. TAS(The Anesthesiologist Society) scope is an indigenously designed video laryngoscope . It is a video intubation aid with an endoscopic camera which can be connected to mobile phones and tablets. There is paucity of literature regarding comparison of efficacy of intubation of the above two devices. Hence this study will be undertaken to evaluate the efficacy of newer TAS scope in comparison McCoy laryngoscope. In this study 100 patients will be divided into two equal groups .one group intubation will be achieved by McCoy laryngoscope and in another group with TAS scope ,intubation will be carried by anaesthesiologist having good experience with McCoy and TAS scope.
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