| CTRI Number |
CTRI/2018/03/012448 [Registered on: 09/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/03/2018 |
| 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
|
Study which makes use of two different devices for placement of a tube to control breathing during anaesthesia |
|
Scientific Title of Study
|
Comparison of King Vision and C-MAC videolaryngoscopes for intubation in adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavya MS |
| Designation |
Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology,
MS Ramaiah Medical College and Hospitals,
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
ms.kavya2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tejesh CA |
| Designation |
Associate Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology,
MS Ramaiah Medical College & Hospitals,
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
drtejeshca@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejesh CA |
| Designation |
Associate Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology,
MS Ramaiah Medical College & Hospitals,
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
drtejeshca@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Investigators,
Dr.Kavya PG, Resident
Dr.Tejesh CA, Associate Professor.
Department of Anaesthesiology,
MS Ramaiah Medical College, Bangalore |
|
|
Primary Sponsor
|
| Name |
Tejesh CA |
| Address |
MS Ramaiah Medical College & Hospitals,
Bangalore |
| Type of Sponsor |
Other [Self funding by Investigators] |
|
|
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 |
| Kavya MS |
MS Ramaiah Hospital |
Department of Anaesthesiology,
Bangalore
KARNATAKA |
9035582232
ms.kavya2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee MS Ramaiah College & Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients without any co-morbid conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
C-Mac videolaryngoscope |
C-Mac videolaryngoscope will be used for endotracheal intubation |
| Intervention |
King-vision videolaryngoscope |
King-vision videolaryngoscope will be used for endotracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) Grade I and II
Mallampatti grade I and II
|
|
| ExclusionCriteria |
| Details |
Mallampatti grade ≥ III
BMI >30kg/m2
Thyromental distance <6cm
Inter incisor distance <3cm
Reduced neck extension
Cervical spine instability
Risk of pulmonary aspiration
Pregnancy
Oro-pharyngeal pathology
Facial abnormalities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time for successful intubation with King Vision and C-MAC videolaryngoscopes. |
At the end of endotracheal intubation following induction of general anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare theglottis view, number of attempts, first-attempt success rate and proportion of successful intubation with King Vision and C-MAC videolaryngoscopes |
At end of endotracheal intubation following induction of general anaesthesia |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/11/2016 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized trial to compare the endotracheal intubation with the two videolaryngoscopes, King-vision and C-Mac, for endotracheal intubation in ASA class 1 & 2 adults aged 20-60 years undergoing surgery under general endotracheal anaesthesia. The primary outcome is the time taken for successful intubation with the two devices. The secondary outcomes are the glottic view, number of attempts at intubation, first-attempt success rate and proportion of successful intubation with the two devices. |