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CTRI Number  CTRI/2022/09/045549 [Registered on: 15/09/2022] Trial Registered Prospectively
Last Modified On: 23/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of endotracheal intubation with different laryngoscopic blade in simulated difficult airway condition having restricted neck movement. 
Scientific Title of Study   Comparison of efficacy of intubation with Hugemed non channeled video laryngoscope, McCoy and Macintosh laryngoscope in simulated difficulty laryngoscopy using rigid cervical collar-a prospective randomized trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Greeshma N Murdeshwar 
Designation  Assistant Professor  
Affiliation  Mysore Medical College and Research Institute 
Address  Department of Anesthesiology, Mysore Medical College and Research Institute, Irwin Road, Mysore.

Mysore
KARNATAKA
570015
India 
Phone    
Fax    
Email  greeshma.murdeshwar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Greeshma N Murdeshwar 
Designation  Assistant Professor  
Affiliation  Mysore Medical College and Research Institute 
Address  Department of Anesthesiology, Mysore Medical College and Research Institute, Irwin Road, Mysore.


KARNATAKA
570015
India 
Phone    
Fax    
Email  greeshma.murdeshwar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yashodha V 
Designation  Assisstant Professor 
Affiliation  Mysore Medical College and Research Institute 
Address  Department of Anesthesiology, Mysore Medical College and Research Institute, Irwin Road, Mysore.

Mysore
KARNATAKA
570015
India 
Phone    
Fax    
Email  yashdvg12@gmail.com  
 
Source of Monetary or Material Support  
Mysore Medical College and Research Institute. 
 
Primary Sponsor  
Name  Mysore Medical College and research Institute 
Address  Irwin Road, Mysore 
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 Greeshma N Murdeshwar  K R Hospital  Ground floor, First floor and Second Floor operation Theathres, Department of Anesthesiology, Stone building, Near Dhanavantri road, MMC&RI, Mysore
Mysore
KARNATAKA 		 9741775106

greeshma.murdeshwar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mysore Medical College and Research Institute.  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, (2) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Videolayngoscopic blade for intubation.  Newer variety of video laryngoscopic blade Hugemed Blade has an angulation of 66 degrees for ease of insertion in oral cavity and easy visualisation of vocal cords compared to various other laryngoscopic blade.Trial will be conducted for 8 months. 
Comparator Agent  Comparision with Maccoy blade and conventional Machintosh blade.  Both these blades are compared with newer videolaryngoscopic blade in simulated difficult airway with restricted neck extention using rigid cervical collar. Trial duration will be 8 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients posted for surgery under general anesthesia will be included with American Society of Anesthesiology (ASA) grade I or II, having body mass index (BMI) less than 25-35kg/m2 having Mallampatti grade of 1 or 2. 
 
ExclusionCriteria 
Details  age less than 18 years and more than 60 years
obese patients
difficult airway 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary objective is to assess intubation difficulty score. Also time taken for intubation was assessed.  baseline, 1 minute, 3 minutes, 5 minutes and 10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objectives are to assess ease of laryngoscope blade insertion into the oral cavity and detect if there are any complications  baseline, 1 minute, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 9 hours, 24 hours 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/09/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet enrolment of the participants started. waiting for the ctri number for our prospective trial 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 06-01-2023 and end date provided 06-01-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Securing the airway is very essential during general anesthesia procedure. There are many laryngoscopic blade for the same. In our study we will compare a newer videolaryngoscopic blade- Hugemed videolaryngoscopic blade with  Maccoy and the conventional Machintosh blade. Hence there will be three groups with 50 patients in each group. After obtaining the informed consent, we will conduct the study in patients posted for surgery under general anesthesia needing endotracheal intubation meeting the other inclusion criteria as mentioned. Computer based randomised will be done. We will try to simulate the difficult airway by using the rigid cervical collar which will restrict the neck extension , just before the intubation. We will use premedications , inducing agent propofol and vecuronium as mescle relaxants. Anesthesia will be maintained by nitrous oxide and volatile agents. intubation will be attempted by trained anesthesiologist. When intubation is attempted depending on the group, the intubation difficulty score as described by Adnet et al. and time taken for intubation will be noted as our primary objective states. We will also note the difficulty in laryngoscopic blade insertion and any complications as our secondary objective states. data will be collected in preformed proforma. Blinding of the participant and data analyser can be done. But blinding of the investigator will be difficult to be maintained.
Further the patient will be monitored throughout the surgery and reversed and then extubated. Any adverse effect or complications during this period will be noticed. Statistical data will be analysed using SPSS software 28.
 
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