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CTRI Number  CTRI/2017/09/009793 [Registered on: 15/09/2017] Trial Registered Prospectively
Last Modified On: 23/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two techniques for introducing tube into the trachea of patients given general anaesthesia for routine surgeries, using a device called video laryngoscope (C-MAC)- with and without a tracheal introducer called bougie. 
Scientific Title of Study   Comparison of intubation by anaesthesia residents using C-MAC C-blade video laryngoscope- with and without bougie: A randomized 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 Meenu Priya A 
Designation  Junior resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Department of Anesthesiology and Critical care, Dhanvantari Nagar, JIPMER, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  7598519887  
Fax    
Email  meenupriya1193@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priya Rudingwa 
Designation  Assistant Professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Department of Anaesthesiology and Critical care, Dhanvantari Nagar, JIPMER, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  8903477132  
Fax    
Email  priyaab8@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Meenu Priya A 
Designation  Junior resident  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Department of Anaesthesiology and Critical care, Dhanvantari Nagar, JIPMER, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  7598519887  
Fax    
Email  meenupriya1193@gmail.com  
 
Source of Monetary or Material Support  
Intramural Grant for Postgraduate Research in Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Puducherry, India. Pin- 605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Dhanvantari Nagar, JIPMER, Puducherry, 605006. 
Type of Sponsor  Research institution and hospital 
 
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 Meenu Priya A  Jawaharlal Institute of Postgraduate Medical Education and Research   Anaesthesiology office, 2nd floor, hospital block, Department of Anaesthesiology and Critical care, JIPMER, Dhanvantari Nagar, Puducherry.
Pondicherry
PONDICHERRY 		 7598519887

meenupriya1193@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER Institute Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  1.adults between 18-60 years age. 2.those undergoing elective surgery planned for orotracheal intubation. 3.ASA class 1-2, (1) ICD-10 Condition: H701||Chronic mastoiditis, (2) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (3) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  C-MAC guided intubation with bougie   Endotracheal intubation will be done by anaesthesia residents using C-MAC C-blade video laryngoscope with bougie. 
Comparator Agent  C-MAC guided intubation without bougie  Endotracheal intubation will be done by anaesthesia residents using C-MAC C-blade video laryngoscope without bougie. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients with age 18-60 years undergoing elective surgery in JIPMER, belonging to ASA class 1-2 planned for general anaesthesia with orotracheal intubation will be included in the study. 
 
ExclusionCriteria 
Details  1. Pregnant women 2. Patients with aspiration risk and those requiring rapid sequence induction 3. Patients planned for awake fiber-optic or nasal intubation 4. Patients with difficult airway which includes mouth opening less than 3 centimetres, Mallampatti class 3 or more, thyromental distance less than 6 centimetres, restricted neck extension. 5. Patients not willing for the study. 
 
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 intubation by anaesthesia residents using C-MAC C-blade video laryngoscope-with bougie and without bougie guided endotracheal tube.  Duration in seconds. The time for intubation will be recorded as the interval between the introduction of C-MAC C-blade into the patients mouth to the appearance of End tidal carbon dioxide trace in the monitor. It is done during intubation under general anaesthesia. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the laryngoscopy time in each technique.
 		 Duration in seconds. Time for laryngoscopy is recorded as the time interval between the introduction of C-MAC C-blade into the patients mouth to the visualisation of glottis in the screen. It is done during intubation under general anaesthesia. 
To compare the number of attempts at redirection of the tube and the number of failed intubations in each technique.  The number of failed intubation and the number of times of tube redirection is noted during intubation. 
To compare the user review regarding the ease of intubation in each technique.  The intubators opinion regarding the ease of intubation is assessed using an ordinal scale. 1- very easy, 2- easy, 3- moderately difficult, 4- very difficult. It is done after intubation. 
To assess and compare the hemodynamic responses associated with each technique. {Heart rate(HR), Blood pressure(BP)}  Baseline heart rate and blood pressure in beats per minute and millimetres of mercury respectively is noted before induction, then every one minute from the time of intubation for 5 minutes. 
To compare the need for external laryngeal maneuvers and the number of times of repositioning of C-MAC C-blade needed for each technique.  It is done during intubation of trachea. 
To assess and compare postoperative pharyngolaryngeal complaints of the patients.( sore throat, throat pain, dysphonia, dysphagia) and To record any episodes of desaturation.  Patient will be reviewed 24 hours after the surgery to assess for presence of sore throat, throat pain, dysphonia or dysphagia. 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "162"
Final Enrollment numbers achieved (India)="162" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2018 
Date of Study Completion (India) 10/07/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/07/2019 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 under process 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		      C-MAC video laryngoscope is trending as the routine standard of care in western countries. It is also expected to become so in all other places in future. The view obtained on a video laryngoscope screen may not always correspond to ease of intubation as it is an indirect view and does not correspond to the line of sight. Thus various aids like stylets, bougie or forceps might be used while intubation. As C-MAC laryngoscope is similar to a Macintosh laryngoscope without an acute angle the manufacturer does not recommend use of a stylet but people have been using it with or without stylet depending on their preferences. A stylet due to its stiff nature when used with video laryngoscopes has been found to cause pharyngeal wall injuries. Compared to the rigid stylet, bougie is stiff yet a flexible device with little incidence of injury to soft tissue. A bougie due to its smaller diameter and bent tip can be easily negotiated into the larynx. It has been shown that bougie improves the success rates of intubation with direct laryngoscopy especially in novice learners even with less instruction and practice. Therefore, this study aims to compare intubation using C-MAC laryngoscope by anaesthesia residents with and without bougie guided endotracheal tube. 

      Some studies have compared angulated C-MAC D-blade laryngoscope using bougie and stylet guided endotracheal tube and others have compared C-MAC C-blade with direct laryngoscopy. But no studies are available so far combining the use of C-MAC C-blade with bougie or without bougie guided endotracheal tube under routine conditions. In this study we compare two techniques for endotracheal intubation by anaesthesia residents using C-MAC C-blade video laryngoscope- with bougie and without bougie in patients planned for routine endotracheal intubation during general anaesthesia.

      The study hypothesis is that endotracheal intubation by anaesthesia residents using C-MAC laryngoscope with bougie guided endotracheal tube will take less time when compared to using C-MAC without bougie guided endotracheal tube.

 
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