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CTRI Number  CTRI/2018/05/013598 [Registered on: 02/05/2018] Trial Registered Retrospectively
Last Modified On: 16/04/2018
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 two types of layngoscopes for intubation in patients undergoing cervical spine surgery.  
Scientific Title of Study   Comparative evaluation of a videolaryngoscope with a direct laryngoscope for tracheal intubation with manual in line stabilization of neck in patients undergoing cervical spine surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Astha Kumari 
Designation  Post graduate resident first year 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Dr Astha Kumari,PG 1st year, Department of Anaesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi -110029

New Delhi
DELHI
110029
India 
Phone  9582024435  
Fax    
Email  drastha2016@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nidhi Agrawal 
Designation  Senior Consultant and Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi -110029

New Delhi
DELHI
110029
India 
Phone  9811030408  
Fax    
Email  nidhi.agrawal1970@gmail.com  
 
Details of Contact Person
Public Query  
Name  Astha Kumari 
Designation  Post graduate resident first year 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Dr Astha Kumari,PG 1st year, Department of Anaesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi -110029

New Delhi
DELHI
110029
India 
Phone  9582024435  
Fax    
Email  drastha2016@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital  
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesiology Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi -110029 
Type of Sponsor  Government medical college 
 
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 
Astha Kumari  Vardhman Mahavir Medical College and Safdarjung Hospital  Main OT complex,Department of Anaesthesiology, New Delhi -110029
New Delhi
DELHI 		 9582024435

drastha2016@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients of cervical spine injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CMAC D-blade  CMAC D-blade for intubation in patients of cervical spine injury undergoing surgery 
Comparator Agent  Mc coy laryngoscope  Mc coy laryngoscope for intubation in patients of cervical spine injury undergoing surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  study will be conducted on
a) 60 adult patients of 18-60 years of age ,
b) either sex and
c) American society of Anaesthesiologists (ASA) physical status I , II and III
d)scheduled to undergo elective cervical spine surgery requiring tracheal intubation with manual in line stabilization of neck under general anaesthesia. 
 
ExclusionCriteria 
Details  a) Patients with following predictors of difficult airway :
1)Modified Mallampati class IV,
2)Interincisor distance < 4.0 cm,
3)Upper lip bite test class >1,
4)Buck teeth and poor dentition with high risk of damage,
5)Oropharyngeal pathology or facial abnormality,
6)BMI >30kg /metre2.
b) Haemodynamic or pulmonary compromise, high risk of pulmonary aspiration and cardiac disease and Hypertension.
c) Pregnancy 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare Intubation difficulty scale score with C-MAC D-blade videolaryngoscope and McCoy laryngoscope for tracheal intubation with manual in line stabilization of neck in the study population  At the time of intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Total time taken to secure the airway,
Number of intubation attempts ,
Ease of insertion of laryngoscope and
Percentage of glottic opening score (POGO score ) during a laryngoscopy and intubation attempt  		 At the time of intubation. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   06/11/2017 
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   1.Jain D, Dhanka M, Wig J, Jain A.Comparison of the conventional CMAC and the D-blade CMAC with the direct laryngoscopes in simulated cervical spine injury—a manikin study. Braz J Anesthesiol 2014;64:269-74 2.Sabry LA, Shaarawy SS, Ellakany MH, Elmasry AA. Comparison between C-MAC D-blade and McCoy laryngoscopes in intubating patients during cervical immobilization. Res Opin Anesth Intensive Care 2016;3:122-8. 3.Shravanalakshmi D, Bidkar PU, Narmadalakshmi K, Lata S, Mishra SK, Adinarayanan S. Comparison of intubation success and glottic visualization using King Vision and C-MAC videolaryngoscopes in patients with cervical spine injuries with cervical immobilization: A randomized clinical trial.Surg Neurol Int 2017;8:19.(published online) 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
PRIMARY OBJECTIVE 
 To compare intubation difficulty scale score with C-MAC D-blade videolaryngoscope and McCoy laryngoscope for tracheal intubation with manual in line stabilization of neck  in the study population. 

SECONDARY OBJECTIVES
To compare total time taken to secure the airway, number of intubation attempts, ease of insertion of the laryngoscope and percentage of glottic opening score  with C-MAC D-blade videolaryngoscope  and McCoy laryngoscope in the study population.

HYPOTHESIS
C-MAC D-blade videolaryngoscope will provide better glottic visualization and decrease intubation difficulty as compared to McCoy laryngoscope in patients with cervical spine immobilization.

 
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