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CTRI Number  CTRI/2025/08/092318 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 03/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of the clinical performance of two airway securing devices (McCoy Laryngoscope and CMAC D Blade videolaryngoscope) in patients who require fast airway securing and neck immobilisation while undergoing surgery under general anaesthesia . 
Scientific Title of Study   Comparative evaluation of McCoy and CMAC D-Blade laryngoscope for rapid sequence intubation in patients with simulated restricted neck mobility 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Joshi 
Designation  Junior Resident (PG) 
Affiliation  Government Medical College and Hospital, Sector 32, Chandigarh  
Address  Department of Anaesthesia and Intensive Care, Level 5, D block, Government Medical College and Hospital, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9464679030  
Fax    
Email  rahuljoshi65656@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dheeraj Kapoor 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Sector 32, Chandigarh  
Address  Department of Anaesthesia and Intensive Care, Level 5, D Block, Government Medical College and Hospital, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121549  
Fax    
Email  kapoordheeraj72@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manpreet Singh 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Sector 32, Chandigarh  
Address  Department of Anaesthesia and Intensive Care, Level 5, D Block, Government Medical College and Hospital, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121503  
Fax    
Email  manpreetdawar@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care Level 5 , D Block , Government Medical College and Hospital , Sector 32 Chandigarh  
 
Primary Sponsor  
Name  Department of Anaesthesia and Intensive care GMCH Chandigarh  
Address  Department of Anaesthesia and Intensive Care Level 5 , D Block , Government Medical College and Hospital , Sector 32 Chandigarh 
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 
Dr Rahul Joshi  Government Medical College and Hospital , Sector 32, Chandigarh, 160030   Department of Anaesthesia and Intensive Care, D Block, 5th Floor, Government Medical College and Hospital, Sector 32 , Chandigarh
Chandigarh
CHANDIGARH 		 9464679030

rahuljoshi65656@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE(GMCH,Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endotracheal Intubation Using McCoy Laryngoscope  McCoy introduced a change in conventional Macintosh laryngoscope by introducing a hinged tip that elevates, when the proximal lever attached to the handle is pressed. This lever mechanisms, may improve the glottic opening visibility, hence improving the Cormack-Lehane grades used for glottic visualization. In addition, it may also attenuates the hemodynamic stress response during intubation . In the study patient will be preoxygenated with 100 percent oxygen for 3 minutes in neutral position , followed by cricoid pressure of 10 N , followed by induction using inj. Fentanyl , Inj. Propofol , after the loss of verbal response , inj. suxamethonium chloride will be given and cricoid pressure of 30 N will be applied simultaneously . After one minute of suxamethonium chloride MILS technique will be achieved . Laryngoscopy will be conducted using McCoy laryngoscope and trachea of patient will be intubated using endotracheal tube primed with malleable stylet . The primary objective is to compare the time taken for endotracheal intubation with the McCoy and CMAC D-Blade laryngoscope using rapid sequence intubation technique in patients with simulated restricted neck mobility . 
Comparator Agent  Endotracheal Intubation with CMAC D-Blade Videolaryngoscope  Videolaryngoscopes has gained widespread adoption by airway managers, owing to its unique characteristics of providing enhanced viewing angle without application of undue tractional forces. The tip of these videolaryngoscopes have light source and a micro camera, designed to provide better visualisation of the glottic opening. These devices leads to dynamic monitoring of the tracheal intubation and positioning, hence reducing the probability of inadvertent oesophageal intubation or any soft tissue injuries. The CMAC videolaryngoscope system incorporates an advanced CMOS sensor camera integrated with a high-luminosity light source, enabling superior glottic visualization during airway management .The system have two blades, C Blade which is a prototype of the Macintosh blade and the D-Blade, which is hyperangulated and has channel for facilitating para-oxygenation. The CMAC D-Blade bypasses the requirement for traditional airway axis alignment necessary in conventional laryngoscopy, thereby facilitating direct visualization of the vocal cords without mandibular or cervical spine manipulation. In the study patient will be preoxygenated with 100 percent oxygen for 3 minutes in neutral position , followed by cricoid pressure of 10 N , followed by induction using inj. Fentanyl , Inj. Propofol , after the loss of verbal response , inj. suxamethonium chloride will be given and cricoid pressure of 30 N will be applied simultaneously . After one minute of suxamethonium chloride MILS technique will be achieved . Laryngoscopy will be conducted using CMAC D Blade videolaryngoscope and trachea of patient will be intubated using endotracheal tube primed with malleable stylet . The primary objective is to compare the time taken for endotracheal intubation with the McCoy and CMAC D-Blade laryngoscope using rapid sequence intubation technique in patients with simulated restricted neck mobility . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age group of 18 to 60 years of either gender.
2.Patients with the American Society of Anaesthesiologists (ASA) physical status Class I and II.
3.Patients undergoing elective surgery requiring endotracheal intubation under general anaesthesia.
 
 
ExclusionCriteria 
Details  1.Patients with anticipated difficult airway [Airway Difficulty Score (ADS)more than 8]
2.Morbid obesity (BMI more than 35kg per meter square).
3.Pregnant women.
4.Major maxilla facial trauma or cervical spine pathology.
5.Severe cardiorespiratory, cerebrovascular, renal, lymphatic and musculoskeletal diseases.
6.Severe coagulopathy or history of anticoagulant use.
7.Patients at increased risk of pulmonary aspiration such as gastroesophageal reflux disease (GERD), peptic ulcer disease.
8.Surgeries in prone position.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the time taken for endotracheal intubation with the McCoy and CMAC D-Blade laryngoscope using rapid sequence intubation technique in patients with simulated restricted neck mobility.  Time between clear laryngeal view to appearance of first square wave capnograph is obtained .  
 
Secondary Outcome  
Outcome  TimePoints 
To compare Time taken for laryngoscopy .  Time between introduction of device in mouth till the clear view of glottis is obtained  
To compare the Total time taken for intubation  Time from introduction of device in mouth till first square wave capnograph is obtained  
To compare the number of attempts for successful intubation  Number of attempts taken till first square wave capnograph is obtained .  
To compare the laryngeal view obtained   after obtaining clear laryngeal view during laryngoscopy 
To compare hemodynamic parameters   To compare hemodynamic parameters preoperatively,just before insertion, immediately after insertion, 1 minute, 5 minutes & 10 minutes after intubation 
Any other complications-
soft tissue oedema , dental trauma, bleeding from gums/ lips . 		 during insertion of the device , during the surgical procedure . 
Post operative Complications such as sore throat, stridor or hoarseness   Complications such as sore throat, stridor or hoarseness to be noted after extubation for 12 hours . 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   16/08/2025 
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)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rahuljoshi65656@gmail.com].

  6. For how long will this data be available start date provided 11-08-2025 and end date provided 11-01-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study compares endotracheal intubation time using the CMAC D Blade videolaryngoscope and McCoy laryngoscope during Rapid Sequence Intubation (RSI) with Manual In Line Stabilization (MILS) in patients with restricted neck mobility. Endotracheal intubation is crucial for airway management, but cervical immobilization disrupts optimal positioning , which complicates laryngoscopy . While the CMAC D Blade offers enhanced glottic visualization without  requirement of alignment of oral , oropharyngeal and laryngeal axis ; the levering mechanism of McCoy laryngoscope may improve Cormack Lehane grades. RSI, involving cricoid pressure (Sellicks maneuver), which further challenges intubation by obscuring the view. Existing studies show conflicting results on intubation times between these devices, with some favoring CMAC D Blade and others favour McCoy . This study hypothesizes that the McCoy laryngoscope will enable faster intubation due to direct line of sight and reduced hand eye coordination demands compared to the CMAC D Blade. The findings aim to guide optimal device selection in patients with restricted neck mobility , balancing speed and success to minimize hypoxemia and aspiration risks during emergency intubation.

Aims :

To compare McCoy and CMAC D-Blade laryngoscope for rapid sequence intubation in patients with simulated restricted neck mobility .

Objective :

·       To compare the time taken for endotracheal intubation with the McCoy and CMAC D Blade laryngoscope using rapid sequence intubation technique in patients with simulated restricted neck mobility.

·       To compare the glottic view (Modified Cormack Lehane grading and POGO score), duration of laryngoscopy to obtain the glottic view, total duration for endotracheal intubation and first attempt success rate of endotracheal intubation with the two with the McCoy and CMAC D Blade laryngoscope using rapid sequence intubation technique in patients with simulated restricted neck mobility. devices.

·       To compare the hemodynamic parameters in patients undergoing tracheal intubation and post operative adverse events with the two devices. 


Following observations will be recorded in all the patients:

1.     Time taken for laryngoscopy (TL) : Time between introduction of device till the clear view of glottis

2.     Time taken for endotracheal intubation (TI) : Time between clear laryngeal view to appearance of first capnography waveform.

3.     Total time taken for intubation (TTI) from introduction of device in mouth till first square wave capnograph is obtained

4.     The number of attempts until the tube is in tracheal, as confirmed by capnography and chest auscultation.

5.     Laryngeal view obtained (Modified Cormack and Lehane grading and Percentage of Glottis Opening (POGO) score by the airway manager.

6.     Heart rate (HR), NIBP, SpO2 and ETCO2 will be monitored continuously throughout the procedure and recorded just before intubation, immediately after intubation, at 1 minute after intubation, 5 minutes after  intubation and 10 minutes after intubation.

7.     Any other intra operative finding:

a)     Broken Teeth

b)    Soft tissue oedema

c)     Bleeding from gums/lips

8.     Postoperative observations: All patients will be evaluated in the post anaesthesia care unit (PACU) and in the ward for a duration of 12 hours for the following observations:

a)     Sore throat

b)    Stridor/hoarseness

c)     Any other complication

 
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