Plain English Summary
Background and study aims
Direct laryngoscopy (DL) is a procedure using a small flexible tube with a light and video camera at one end (laryngoscope) which is inserted through the mouth to examine the larynx (voicebox) during tracheal intubation (insertion of a plastic tube into the airway during surgery under general anesthesia. It can cause a high heart rate (tachycardia) and high blood pressure which could be fatal in a patient with a brain injury. Bonfils fiberscope and C-MAC videolaryngoscope are two methods of laryngoscopy associated with more stable blood flow variables (hemodynamics) compared to DL. The aim of this study is to determine the hemodynamic effects of Bonfils compared to C-MAC in patients undergoing elective surgery.
Who can participate?
Adults aged 18 – 60 years old undergoing elective surgery
What does the study involve?
Participants are randomly assigned to one of two groups. Those in the first group receive intubation with Bonfils fiberscope, and those in the second group receive C-MAC videolaryngoscopy, whilst under general anaesthetic. Heart rate and blood pressure are recorded throughout the surgery.
What are the possible benefits and risks of participating?
There are no additional benefits or risks associated with these interventions as they are both frequently used in clinical practice.
Where is the study run from?
Centre Hospitalier Universitaire de Sherbrooke (Canada)
When is the study starting and how long is it expected to run for?
October 2013 to January 2016
Who is funding the study?
University of Sherbrooke (Canada)
Who is the main contact?
Dr Frederick D’Aragon (Scientific)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Frederick D'Aragon
ORCID ID
http://orcid.org/0000-0003-1323-0449
Contact details
Department of Anesthesiology
Faculty of Medicine and Health Sciences
University of Sherbrooke
3001 12th Avenue North
Sherbrooke
J1H 5N4
Canada
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
None
Study information
Scientific title
Hemodynamic responses to tracheal intubation with Bonfils compared to C-MAC videolaryngoscope: a randomized trial
Acronym
Study hypothesis
Intubation using Bonfils would increase mean arterial pressure and heart rate less than with C-MAC
Ethics approval
Étienne Le Bel Clinical research Centre (Centre de recherche clinique Étienne-Le-Bel), 18/08/2014, ref:14-111
Study design
Single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
General anesthesia for elective surgery
Intervention
Participants are randomly assigned in a 1:1 ratio through a computer generated sequence, to receive intubation with Bonfils or C-MAC. After a standardized induction, intubation is done via the retromolar approach (Bonfils group) or via videolaryngoscopy (C-MAC group). Participants have heart rate (HR) and arterial blood pressure (systolic, diastolic and mean arterial blood pressure [MAP]) measured at induction and at every minute during the five minutes post intubation.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Hemodynamic response to intubation is measured using heart rate (HR) and arterial blood pressure (systolic, diastolic and mean arterial blood pressure [MAP]) at induction and every minute for the first five minutes post intubation.
Secondary outcome measures
Duration of intubation (defined as introduction of Bonfils or C-MAC in the oral cavity until confirmation of proper positioning of the endotracheal tube) is measured by a positive capnography reading.
Overall trial start date
01/10/2013
Overall trial end date
25/01/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Elective surgery
2. Classified as American Society of Anesthesia (ASA) 1 or 2
2. Aged 18-60 years old.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Patient refusal
2. Known Cormack-Lehane grade ≥ 2
3. Known Mallampati > 2
4. Known Patil < 4 cm
5. Mouth opening < 3 cm
6. Active smoking
7. Chronic hypertension.
Recruitment start date
01/09/2014
Recruitment end date
23/08/2015
Locations
Countries of recruitment
Canada
Trial participating centre
Centre Hospitalier Universitaire de Sherbrooke
300, 12th Avenue North
Sherbrooke
J1H 5N4
Canada
Sponsor information
Organisation
Department of Anesthesiology, Faculty of Medicine and Health Sciences
Sponsor details
Department of Anesthesiology
Faculty of Medicine and Health Sciences
University of Sherbrooke
3001 12th Avenue North
Sherbrooke
J1H 5N4
Canada
+1 819 821-8000
Anesthesie-Med@USherbrooke.ca
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Université de Sherbrooke
Alternative name(s)
University of Sherbrooke, UdeS
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Canada
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement: The datasets generated during and/or analysed during the current study will be stored in a publically available repository (Registry of Open Access Repositories, weblink: http://roar.eprints.org/cgi/users/home?screen=Items). Type of data available: non sensitive data at the patient level, anonymised, and available after 3 months. To request access please contact the Frederick D'Aragon (study PI).
Intention to publish date
25/01/2019
Participant level data
Stored in repository
Basic results (scientific)
See additional file: 34923_BasicResults_12Mar18
Publication list
Publication citations
Additional files
- 34923_BasicResults_12Mar18.pdf Uploaded 26/03/2018