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CTRI Number  CTRI/2020/09/028011 [Registered on: 24/09/2020] Trial Registered Prospectively
Last Modified On: 24/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   This study is to see the effects of three types of Laryngoscopes in patients undergoing general anesthesia for spine problem.  
Scientific Title of Study   Comparison of C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with standard blade, and Macintosh Laryngoscopes for intubation with cervical spine immobilization: a 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 Niraj Kumar 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no – 709 7th floor Deptt of Neuroanesthesiology and Critical Care Neuroscience center AIIMS New Delhi.

New Delhi
DELHI
110029
India 
Phone  9013770806  
Fax    
Email  drnirajaiims@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Niraj Kumar 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no – 709 7th floor Deptt of Neuroanesthesiology and Critical Care Neuroscience center AIIMS Delhi

New Delhi
DELHI
110029
India 
Phone  9013770806  
Fax    
Email  drnirajaiims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Niraj Kumar 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no – 709 7th floor Deptt of Neuroanesthesiology and Critical Care Neuroscience center AIIMS Delhi

New Delhi
DELHI
110029
India 
Phone  9013770806  
Fax    
Email  drnirajaiims@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Ansari Nagar, New Delhi. 110029 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Niraj Kumar  AIIMS, New Delhi  Dr Niraj Kumar Room no – 709 7th floor Deptt of Neuroanesthesiology & Critical Care Neuroscience center AIIMS Delhi-110029
New Delhi
DELHI 
9013770806

drnirajaiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cervical Myelopathy, (1) ICD-10 Condition: G00-G99||Diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with standard blade   In group 2, C-MAC video-laryngoscope with standard blade and in group 3, C-MAC video-laryngoscope with D-Blade will be used for endotracheal intubation. 
Comparator Agent  Macintosh Laryngoscope  In group 1(control) Macintosh Laryngoscope will be used for endotracheal intubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 18 and 60 years of either gender belonging to ASA physical status I–II undergoing elective cervical spine surgery requiring GA 
 
ExclusionCriteria 
Details  Patients with risk factors for difficult mask ventilation
Patients with risk factors for gastric aspiration (obesity)
Patients with difficult airway such as previous neck surgery and mouth opening less than 3 cm will be excluded from the study.
Anticipated difficult airway including Mallampati grade 3 and 4 airway
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Cormack Lehane (CL) grade of laryngoscopic view  at the point when blade of the laryngoscope is placed inside the mouth  
 
Secondary Outcome  
Outcome  TimePoints 
Time taken for successful intubation
Success rate of first attempt intubation
No of attempts of intubation
Number of optimization manoeuvres required
Complications
Difficulty score laryngoscope blade will be noted
Hemodynamic changes
 
-time from insertion of the laryngoscope blade until first appearance of the capnograph waveform
Hemodynamic changes - (before induction, after induction, immediately after intubation than every minute until 5 min after intubation).

 
 
Target Sample Size   Total Sample Size="123"
Sample Size from India="123" 
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)   01/10/2020 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Title: Comparison of C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with standard blade, and Macintosh Laryngoscopes for intubation with cervical spine immobilization: a randomized study.

             Macintosh laryngoscope is the most commonly used device for intubation in anesthesia practice. Difficult intubation still a major cause of morbidity and mortality associated with anaesthesia. Recently, viedeolaryngoscopes are becoming very popular for difficult intubation management because it increases glottic view and the success of intubation. There are many studies which show C-MAC viedeolaryngoscopes improves laryngeal view compared to direct laryngoscopy. Manual in-line stabilization (MILS) is used during procedures like airway management in patients with C-spine injury to minimize cervical movement. But MILS make the intubation difficult by decreasing the view of laryngoscopy.        A new C-MAC D-Blade is introduced which can be used as an alternative in difficult airway situations. The advantage of the C-MAC video-laryngoscope with a D-Blade in presence of cervical spine immobilization is not known. The purpose of this randomized controlled study is to com­pare the C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with a standard blade, and Macintosh Laryngoscopes for intubation for endotracheal intubation under general anaesthesia with manual in-line stabilization (MILS).

The primary objective is to compare the Cormack Lehane (CL) grade of laryngoscopic view between C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with standard blade, and Macintosh Laryngoscopes in patients undergoing general anesthesia (GA) using MILS. Following approval of Institute Ethics Committee, 123 patients in between the age group of 18-60 years, will be enrolled in a prospective, randomized, parallel group, multiple arm trial study. Patients aged between 18 and 60 years of either gender belonging to ASA physical status I–II undergoing elective cervical spine surgery requiring GA will be included.

         The patients will be randomized to one of the following three groups (41 each) on the basis of a computer-generated randomization chart: Group I: Macintosh laryngoscope (Group M), Group II: C-MAC videolaryngoscope (Group C), Group III: C-MAC D video laryngoscope (Group D).

            All patients enrolled for the study will receive general anesthesia with tracheal intubation. The neck will be immobilized using MILS by holding the sides of the neck and the mastoid processes, thus preventing flexion/extension or rotational movements of head and neck. Cormack Lehane (CL) grade will be assessed after the first attempt of laryngoscopy. Primary outcome measure will be Cormack Lehane (CL) grade of laryngoscopic view. The secondary outcome will be time taken for successful intubation, success rate of first attempt intubation, number of attempts of intubation, number of optimization maneuvers required to aid tracheal intubation, complication,  difficulty score and Hemodynamic changes during the intubation process.

 
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