| CTRI Number |
CTRI/2021/04/033144 [Registered on: 27/04/2021] Trial Registered Prospectively |
| Last Modified On: |
27/04/2021 |
| 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 video based and non video based laryngoscope during anasthesia. |
|
Scientific Title of Study
|
Effectiveness of McCoy laryngoscopy and C-MAC D video laryngoscopy blade
in managing predicted difficult airway under EEG entropy based anesthesia – A single blind
randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RANJAN NAYAK |
| Designation |
DNB RESIDENT |
| Affiliation |
BANGALORE BAPTIST HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
BANGALORE BAPTIST HOSPITAL
BELLARY ROAD
HEBBAL
BANGALORE 560024 RANJAN NAYAK
SAMETHADKA HOUSE
ARYAPU POST
PUTTUR DAKSHINA KANNADA DISTRICT 574210 Bangalore KARNATAKA 560024 India |
| Phone |
9880214265 |
| Fax |
|
| Email |
dr.ranjansnayak@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Reena R kadni |
| Designation |
Senior Consultant |
| Affiliation |
BANGALORE BAPTIST HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
BANGALORE BAPTIST HOSPITAL
BELLARY ROAD
HEBBAL
BANGALORE 560024 DEPARTMENT OF ANESTHESIOLOGY
BANGALORE BAPTIST HOSPITAL
BELLARY ROAD
HEBBAL Bangalore KARNATAKA 560024 India |
| Phone |
9880214265 |
| Fax |
|
| Email |
docreena1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
RANJAN NAYAK |
| Designation |
DNB RESIDENT |
| Affiliation |
BANGALORE BAPTIST HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
BANGALORE BAPTIST HOSPITAL
BELLARY ROAD
HEBBAL
BANGALORE 560024 RANJAN NAYAK
SAMETHADKA HOUSE
ARYAPU POST
PUTTUR DAKSHINA KANNADA DISTRICT 574210 Bangalore KARNATAKA 560024 India |
| Phone |
9880214265 |
| Fax |
|
| Email |
dr.ranjansnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Baptist Hospital |
|
|
Primary Sponsor
|
| Name |
Bangalore Baptist Hospital |
| Address |
Bangalore Baptist Hospital
Bellary Road
Hebbal
Bangalore 560024 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Ranjan Nayak |
Bangalore Baptist hospital |
department of Anesthesiology
1st floor OT complex
Bangalore Baptist Hospital
Bellary Road Hebbal
Bangalore 560024 Bangalore KARNATAKA |
9880214265
dr.ranjansnayak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Baptist Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CMAC laryngoscope |
CMAC laryngoscope is one of indirect laryngoscope meant for videoscope guided intubation this video laryngoscope comes with the original Macintosh blade abd an angulated D blade along with digital camera and high power LED |
| Intervention |
McCoy Laryngoscope |
McCoy laryngoscope has a hinged tip that aids in improving the Cormack AND lehane view bu 1grade by lifting up epiglottis. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status grade 1, 2, 3 patients
• Age 18-70 years of either sex
• Predicted difficult airway with one of the following
o Mallampati classification 3 and 4
o Mouth opening at least or more than 2cm
o Restricted neck movements
o TMD <6 cm
o Short neck/double chin/increased neck circumference/Micro/retrognathia |
|
| ExclusionCriteria |
| Details |
o Patient refusal
o Uncontrolled hypertension. (>140/90 on regular antihypertensive treatment on
o the day of surgery in preoperative area)
o Coronary Artery disease
o Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation Difficulty Scale Score |
At 0,1,3,5 and 10 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify complications associated with both the laryngoscopes, like,injury to lips,gum,oral,dental trauma,and bronchospasm,stridor,laryngospasm,sore throat |
after the surgery in post operative period. |
|
|
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)
|
01/05/2021 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
no publications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endotracheal intubation is an
integral part of general anaesthesia for most of the patients undergoing
surgery. Difficulty in ventilation and failure to intubate are the principal
causes of hypoxemia, aspiration, ischemic brain injury, cardiovascular
complications and possibly leading to death. Airway accessories have been
developed over the years like different types of
blades, airways, bougies, supraglottic devices, fibreoptic laryngoscope
and C-MAC video laryngoscope for better vision and securing the airway.
C-MAC(Concurrent Media
Access Control) video laryngoscope (Karl Storz, Germany) is one of such
indirect laryngoscope meant for videoscope guided intubation. It is introduced
in the oral cavity and the operator views the larynx on the video screen which
guides the intubation.
McCoy laryngoscopy is a
traditional method in use .It has a hinged tip that aids in improving the
Cormack and Lehane laryngoscopic view by 1 grade by lifting up the epiglottis. C-MAC
is not available still in many centres in India.
There are limited
literatures comparing the C-MAC and McCoy laryngoscope in predicted difficult
airway, so we designed a randomised control study to compare the effectiveness
of McCoy and CMAC laryngoscopy in
predicted difficult airway in elective surgeries under EEG entropy-based
anaesthesia. This entropy based anaesthesia will ensure uniform and adequate
depth of anaesthesia during and after intubation when we compare both methods.
In this study, we intend to
compare both techniques for difficult intubation, in terms of success rates. |