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CTRI Number  CTRI/2023/07/055660 [Registered on: 25/07/2023] Trial Registered Prospectively
Last Modified On: 22/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparing 2 equipment for securing airway in patients with neck fractures  
Scientific Title of Study   Comparison of Stylet versus Bougie to assist orotracheal intubation with C-MAC video-laryngoscope(VL) in adults posted for cervical spine fixation : a randomised single blinded clinical 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 Rachel Botelho 
Designation  Lecturer 
Affiliation  Goa Medical COllege 
Address  Department of Anaesthesiolgy Goa Medical College Bambolim- Goa
Goa Medical College
North Goa
GOA
403002
India 
Phone  09850948870  
Fax    
Email  rchlbotelho@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachel Botelho 
Designation  Lecturer 
Affiliation  Goa Medical COllege 
Address  Department of Anaesthesiolgy Goa Medical College Bambolim- Goa
Goa Medical College
North Goa
GOA
403002
India 
Phone  09850948870  
Fax    
Email  rchlbotelho@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rachel Botelho 
Designation  Lecturer 
Affiliation  Goa Medical COllege 
Address  Department of Anaesthesiolgy Goa Medical College Bambolim- Goa
Goa Medical College
North Goa
GOA
403002
India 
Phone  09850948870  
Fax    
Email  rchlbotelho@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesiology goa Medical College Bambolim North Goa Pin code 403202 
 
Primary Sponsor  
Name  Goa Medical College 
Address  Department of Anaesthesiolgy Goa Medical College Bambolim- Goa 
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 Rachel Botelho  goa medical college  Departement of anaesthesiology Goa Medical College
North Goa
GOA 		 09850948870

rchlbotelho@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Goa Medical College Institutional ethics committee  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 
Comparator Agent  Using a bougie to assist intubation via videolaryngoscope  we will be using a bougie in group 1 as adjunct to intubation during videolaryngoscopy 
Intervention  using a Stylet to assist videolarngoscopy  we will be using a stylet in group 1 as adjunct to intubation during videolaryngoscopy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Our study included only patients posted for elective cervical spine fixation, in the age group of 18 to 60 years, American society of Anaesthesiologists (ASA) grade I and II. 
 
ExclusionCriteria 
Details  Patients with restricted mouth opening (less than 3 fingers), Parturients, BMI > 40kg/ m2, patients on beta blockers and calcium channel blockers, patients with high cervical spine injuries 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. to compare the ease of oral intubation using a stylet versus a bougie, under using conventional C-MAC blade   During Laryngoscopy i.e. 5 mins after Administration of muscle relaxant 
 
Secondary Outcome  
Outcome  TimePoints 
1. The time required for intubation
2. Need for external manoeuvres like Backward Upward Rightward Pressure(BURP), External Laryngeal Manipulation
3. Hemodynamic changes
4. number of attempts taken
5. Post operative sore throat, hoarseness of voice, blood at the tip of tube at extubation.
 		 1- 5 mins after muscle relaxant
2- during laryngoscopy (5 mins after muscle relaxant
3-at baseline, 1min and every min for the next 5 min after intubation
4- during intubation
5-at the end of surgery 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   22/08/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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 -  Study Protocol
    Response - Informed Consent Form

  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 - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 01-10-2023 and end date provided 22-07-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   the study is a randomized single blinded study. in the study we will be using a videaolaryngoscope for intubating pateints with cervical spine fracture posted for fixation, group 1 - we will use the stylet as an aid to intubate with the VL and in group 2 - we will use the bougie for the same. we aim thus at coming to a conclusion as to whether the bougie can be a better adjunct to the VL for intubation in these patients. 
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