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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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