| CTRI Number |
CTRI/2018/02/012236 [Registered on: 28/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing how much vocal cord can be seen while videolaryngoscopy during general anaesthesia through direct and indirect method. |
|
Scientific Title of Study
|
Comparison of Direct Vs Indirect Laryngoscopic view by C-MAC Videolaryngoscope |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suresh G |
| Designation |
Assistant Professor in Department of Anaesthesiology |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department Of Anaesthesiology
M S Ramaiah Medical College
MSRIT post, MSR Nagar
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9844191929 |
| Fax |
|
| Email |
gsureshbmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath A C |
| Designation |
Associate Professor in Department of Anaesthesiology |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department Of Anaesthesiology
M S Ramaiah Medical College
MSRIT post, MSR Nagar
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
8123540084 |
| Fax |
|
| Email |
mac_acin@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Mitali |
| Designation |
Post Graduate in Department Of Anaesthesiology |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department Of Anaesthesiology
M S Ramaiah Medical College
MSRIT post, MSR Nagar
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9008420730 |
| Fax |
|
| Email |
priyamitali2000@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah Medical college, MSR Nagar, MSRIT Post,
Bangalore 560054 |
|
|
Primary Sponsor
|
| Name |
Dr Suresh G |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College
Bangalore |
| Type of Sponsor |
Other [person] |
|
|
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 Suresh G |
M S Ramaiah Hospital |
Department Of Anaesthesiology, 2nd Floor,
M S Ramaiah Hospital
Bangalore
Bangalore
KARNATAKA |
9844191929
gsureshbmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical College And Hospitals Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing elective surgeries needing tracheal intubation under general anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
c mac video laryngoscope |
c mac video laryngoscope is used for laryngoscopy for general anaesthesia cases for unanticipated difficult airways |
| Comparator Agent |
Direct and indirect views of C MAC Videolaryngoscope |
First laryngoscopy will be performed with C MAC with the naked eye. The best view obtained will be graded by the first anaesthesiologist without looking at the video monitor. A second anaesthesiologist blinded to the laryngeal view obtained under direct laryngoscopy will grade the laryngeal view on the video monitor. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18-80 years belonging to American Society of Anaesthesiologist (ASA) score I-III undergoing elective surgeries requiring endotracheal intubation
2.Patients having Mallampati grade I-III. |
|
| ExclusionCriteria |
| Details |
1.History of a difficult airway
2.Potential risks factors for difficult intubation (morbidly obese patients with BMI ≥ 40 kg/m2, Mallampati class > III, mouth opening < 3 cm, and restricted neck movement) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Cormack Lehane view by direct or indirect laryngoscope using C-Mac |
After completeing oral intubation of the patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.External laryngeal manevours required
2.Use of aids for intubation like stylet, bougie
|
After completing oral intubation of the patient |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
07/03/2017 |
| 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
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Endotracheal intubation is considered the definitive airway for resuscitation and airway management. The MACINTOSH laryngoscope is the most commonly used device for directly visualizing the structures of larynx and facilitating tracheal intubation. In recent years videolaryngoscopy has played an important role in management of patients with unanticipated difficult airway or failed tracheal intubation. Videolaryngoscopes are relatively new class of airway devices that allow indirect view of laryngeal structures without the necessity of alignment of oral, pharyngeal and tracheal axis.Hence, laryngoscopy performed using videolaryngoscopes has proven to provide superior views compared to direct laryngoscopy in both normal and difficult intubations. C MAC is one of the most recent macintosh blade based videolaryngoscope and it became commercially available in 2009 March in United States.C MAC videolaryngoscope to our knowledge allows clinician to perform both direct and indirect laryngoscopy with the same blade. therefore it serves as innovation for both difficult airway management and as powerful teaching tool. This study will be comparing the laryngoscopy views by direct and indirect laryngoscope using C MAC. |