Condition category
Surgery
Date applied
05/03/2018
Date assigned
19/03/2018
Last edited
10/09/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30193574

Publication citations

Additional files

Editorial Notes

10/09/2018: Publication reference added. 26/03/2018: The basic results of this trial have been uploaded as an additional file. 19/03/2018: Intention to publish date was added.