| CTRI Number |
CTRI/2024/05/067534 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two video intubation aids for orotracheal intubation in patients undergoing elective surgeries under general anaesthesia. |
|
Scientific Title of Study
|
Comparison of TAScope (The Anesthetist Society) Video Laryngoscope versus Channeled King Vision Video Laryngoscope for orotracheal intubation: A randomized 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 |
Dr Sangamesh Nainegali |
| Designation |
Professor |
| Affiliation |
S. Nijalingappa Medical College & HSK Hospital, Bagalkot |
| Address |
Department of Anaesthesiology
SNMC,Bagalkot-587102
Bagalkot
KARNATAKA
587102
India |
| Phone |
9845268463 |
| Fax |
|
| Email |
ndrsangamesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jennifer Daniel |
| Designation |
Junior Resident |
| Affiliation |
S. Nijalingappa Medical College & HSK Hospital, Bagalkot |
| Address |
Department of Anaesthesiology
SNMC,Bagalkot-587102
Bagalkot
KARNATAKA
587102
India |
| Phone |
8289834447 |
| Fax |
|
| Email |
jenniferdan97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangamesh Nainegali |
| Designation |
Professor |
| Affiliation |
S. Nijalingappa Medical College & HSK Hospital, Bagalkot |
| Address |
Department of Anaesthesiology
SNMC,Bagalkot-587102
Bagalkot
KARNATAKA
587102
India |
| Phone |
9845268463 |
| Fax |
|
| Email |
ndrsangamesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,
S. Nijalingappa Medical College and HSK Hospital,
Navanagar, Bagalkot,
Karnataka -587102,
India |
|
|
Primary Sponsor
|
| Name |
S Nijalingappa medical college and HSK hospital |
| Address |
1st floor, Major OT complex, S. Nijalingappa Medical College and HSK Hospital
Navanagar, Bagalkot,
Karnataka, PIN-587102,
India |
| 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 |
S Nijalingappa Medical College |
Major OT Complex, First floor,
S. Nijalingappa Medical College and HSK Hospital, Navanagar, Bagalkot, PIN - 587 102
Bagalkot
KARNATAKA |
9845268463
ndrsangamesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S NIJALINGAPPA MEDICAL COLLEGE AND HANAGAL SHRI KUMARESHWAR HOSPITAL AND RESEARCH CENTRE |
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 |
Channelled King Vision video laryngoscope |
Random allocation into Group KV (intubation using Channelled King Vision video laryngoscope) will be done by computer generated random numbers.
Multi-parameter monitor with electrocardiogram (ECG), non-invasive blood pressure (NIBP), pulse oximetry (SpO2) and ETCO2 monitor will be attached to the patients. All patients will be unvaryingly pre-medicated intravenously 10 minutes before induction. Preoxygenation will be done with 100% oxygen for 5 minutes. Pre-induction vitals, which include Heart rate (HR), Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and Oxygen saturation (SpO2) will be noted. Induction will be done and muscle relaxant will be given to facilitate the intubation. Post induction (i.e., pre–laryngoscopy) vitals will be noted.
An anaesthesiologist having good experience with Channelled King Vision Video laryngoscope will be performing the intubation. In head neutral position the tube will be inserted into the glottis for intubation.
Proper placement of tube in the trachea will be confirmed by the presence of carbon dioxide in the exhaled breath for three consecutive times via capnography. Endotracheal tube will be fixed after confirming equal air entry in both the lungs. Hemodynamic monitoring which includes HR, SBP, DBP, MAP, SPO2 will be recorded immediately after intubation (T0) and for 10 minutes after intubation
at intervals of 2, 4, 6, 8, 10 minutes after intubation. |
| Intervention |
The TAScope (The Anesthetist Society) video laryngoscope |
Random allocation into Group TV (intubation done using TAScope) will be done by computer generated random numbers. Multi-parameter monitor with electrocardiogram (ECG), non-invasive blood pressure (NIBP), pulse oximetry (SpO2) and ETCO2 monitor will be attached to the patients. All patients will be unvaryingly given pre-medications 10 minutes before induction. Preoxygenation will be done with 100% oxygen for 5 minutes. Pre-induction vitals like Heart rate (HR), Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and Oxygen saturation (SpO2) will be noted. Patient will be induced and muscle relaxant will be given to facilitate the intubation. Post induction (i.e., pre–laryngoscopy) vitals will be noted.
An anaesthesiologist having good experience with TAScope will be performing the intubation. Patient will be positioned in head neutral position. After obtaining adequate view of larynx using TAScope, bougie will inserted via the vocal cords onto which the tube tip will be rail-roaded under vision. The bougie will then be taken out.
Proper placement of tube in the trachea will be confirmed by the presence of carbon dioxide in the exhaled breath for three consecutive times via capnography. Endotracheal tube will be fixed after confirming equal air entry in both the lungs. Hemodynamic monitoring which includes HR, SBP, DBP, MAP, SPO2 will be recorded immediately after intubation (T0) and for 10 minutes after intubation, at intervals of 2, 4, 6, 8, 10 minutes after intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1-Elective General anaesthesia surgeries requiring orotracheal intubation
2-ASA Physical status I, II
3-Age between 18-60 years
4-Body mass index between 18-35 kg/m2
5-Patient’s having MPC 1,2,3
|
|
| ExclusionCriteria |
| Details |
1-Patients with hemodynamic and respiratory compromise
2-Less than 1.5 finger mouth opening
3-History of gastroesophageal reflux disease
4-Patients having cervical spine instability
5-Patients having BMI more than 35 kg/m2
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the intubation difficulty score to evaluate intubating performance of TAScope and Channelled King Vision video laryngoscope. |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the intubation success, intubation time, hemodynamic changes and complications of using TAScope and Channelled King Vision Video laryngoscope |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| 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 - NO
|
|
Brief Summary
|
Endotracheal intubation with difficult
airway has always been a challenge in clinical practice.
Although the direct laryngoscope has been the most commonly used, it has its
limitations when comes to difficult airway. With new advances in technology,
intubation using video laryngoscope has been gaining popularity in difficult
airway management as it reduces the incidence of failed intubations and
provides more hemodynamic stability.
This study intends to compare two of the
different airway gadgets, namely Channelled King Vision video laryngoscope (KV)
and the novice TAS (The Anesthetist Society) scope (TV).
The King Vision video laryngoscope is portable
and easy to use, providing an indirect view of the glottis. It consists of a
reusable display and two blade designs- channelled and standard blade.The TAScope is a channelled,
anatomically angulated video intubation aid with an endoscopic camera that can
be connected to a mobile device. It is cost effective compared to other modern
video laryngoscopes, making it handy in a limited resource setting.
Thus the need of more sophisticated and complex airway instruments that are
cumbersome to use and expensive can be reduced to a particular extent with the
increase in use of cost effective TAScope.
Since there is paucity of literature
regarding comparison of these two devices, we intend to undertake this study to
compare their efficacy. |