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CTRI Number  CTRI/2019/09/021358 [Registered on: 20/09/2019] Trial Registered Prospectively
Last Modified On: 21/07/2020
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   Comparative evaluation of ease of orotracheal intubation using two different video laryngoscopes in patients undergoing elective surgeries  
Scientific Title of Study   “COMPARATIVE EVALUATION OF EASE OF OROTRACHEAL INTUBATION USING C-MAC® VIDEO LARYNGOSCOPE VERSUS McGRATH®MAC VIDEO LARYNGOSCOPE IN PATIENTS UNDERGOING ELECTIVE SURGERIES” A PROSPECTIVE RANDOMIZED STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil Kumar Thakur 
Designation  Professor and HOD Anaesthesia 
Affiliation  ESI PGIMSR and Hospital 
Address  Department of Anaesthesia ESI PGIMSR and Hospital Basaidarapur New Delhi-110015

North East
DELHI
110015
India 
Phone  9355341868  
Fax    
Email  dranilthakur@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rafia Khan 
Designation  Post Graduate 
Affiliation  ESI PGIMSR and Hospital 
Address  ESI PGIMSR and Hospital Basaidarapur New Delhi-110015

North East
DELHI
110015
India 
Phone  9899940679  
Fax    
Email  khanrafia40@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rafia Khan 
Designation  Post Graduate 
Affiliation  ESI PGIMSR and Hospital 
Address  ESI PGIMSR and Hospital Basaidarapur New Delhi-110015

North East
DELHI
110015
India 
Phone  9899940679  
Fax    
Email  khanrafia40@gmail.com  
 
Source of Monetary or Material Support  
Institutional Guru Gobind Singh Indraprastha University New Delhi 
 
Primary Sponsor  
Name  Institutional ESI PGIMSR and Hospital 
Address  ESI PGIMSR and Hospital Basaidarapur New Delhi-110015 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Rafia Khan  ESI PGIMSR and Hospital  2nd floor OT complex, Department of Anaesthesia
North East
DELHI 
9899940679

khanrafia40@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ESI-Post Graduate Institute of Medical Sciences and Research,Basaidarapur,NewDelhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Both male and female aged between 18 years to 60 years of age posted for elective surgery under general anaesthesia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  C Mac video Laryngoscope  Direct Laryngoscopy shall be done using the C MAc video laryngoscope 
Comparator Agent  McGRATH® MAC video laryngoscope   Direct Laryngoscopy shall be done using the Mc Grath Laryngoscope 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA
Patients with
ASA grade I / II
Age 18-60 years of either sex
Patient undergoing elective surgeries requiring general anaesthesia and orotracheal
intubation
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA
Patient refusal.
Patients having:
Modified Mallampatti class III or IV
Mouth opening < 2.5cm
Interincisor distance < 3.5 cm
Thyromental distance < 6 cm
Sterno-mental distance < 12 cm
Mandibulo-hyoid distance < 4 cm
Cervical spine instability
BMI >30 kg/m2
Risk of gastric aspiration
Edentulous patients and patients having artificial denture will be excluded from the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Ease of orotracheal tube placement using C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope.  Time (in seconds) to intubate the trachea, starting from picking up the video laryngoscope
to successful placement of endotracheal tube as confirmed by auscultation of breath sounds, and
presence of square wave capnography on monitor will be noted. If more than one intubation attempt is required, time from insertion of the laryngoscope for the first intubation attempt until confirmation of successful intubation by capnography will be considered to be the total intubation time.  
 
Secondary Outcome  
Outcome  TimePoints 
1.Time (in seconds) taken for orotracheal intubation using C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope.
2.Hemodynamic effects and oxygen saturation changes during orotracheal intubation using C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope.
3.Complication/s (if any)
 
1 min, 3 min, 5 min, 7 min and 10 min 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/10/2019 
Date of Study Completion (India) 30/06/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Airway management is one of the most important skills in the field of anaesthesiology. Endotracheal intubation with the help of Macintosh laryngoscope is a gold standard for definitive airway management in patients undergoing surgery requiring general anesthesia.In recent years, video laryngoscopes have gained in popularity. Video laryngoscopy-assisted tracheal intubation has extensively been applied in airway management because of several significant advantages. These include:(1) improved laryngeal visualization without the need for aligning three axes (oral, pharyngeal and laryngeal axes) especially in difficult airway conditions. (2) The high-quality, magnified airway image makes it easy to identify the airway anatomical structures and anomalies, and facilitates manipulation of airway devices. (3) The entire team can see laryngoscopy and intubation process on the monitor, rather than only the intubator. The multi-person visualization feature can facilitate communication and cohesion of team, improve coordination between intubator and assistant.    Non-handle mounted video laryngoscope, that is, C-MAC® video laryngoscope was developed and manufactured by the Karl Storz GmbH & Co. KG (Tuttlingen, Germany) in 1999. Handle mounted video laryngoscope, that is, McGRATH® MAC (Aircraft Medical Edinburgh, Scotland) is a novel, self-contained video laryngoscope, containing a sterile, transparent, single-use blade. The video laryngoscope was originally designed as a device to manage difficult intubation with direct laryngoscopy. Success with the application of any device can be enhanced as experience with the intervention accumulates. If video laryngoscopy is used for all patients, experience and skill would undoubtedly increase, the number of intubation attempts and complications of multiple attempts would decrease, and patient care would improve. It has been suggested that optimal video laryngoscope should be offered to all patients without significant limitations and not restricted to only those considered most difficult.As video laryngoscopes are introduced into clinical practice, it is important to evaluate their clinical performance and safety to establish superiority or equivalence to already existing devices.There are few published studies with regard to comparison of C-MAC® video laryngoscope (non-handle mounted video laryngoscope) and McGRATH® MAC video laryngoscope (handle mounted video laryngoscope) around the world but no such study has been conducted in India. Hence, this study is planned to be conducted in a prospective, randomized manner to compare C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope for their use in patients undergoing elective surgery under general anesthesia in adult Indian population.

 
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