Comparison between two techniques of endotracheal intubation on blood pressure and heart rate in patient undergoing general anesthesia for elective surgery
| ISRCTN | ISRCTN16349017 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16349017 |
| Secondary identifying numbers | None |
- Submission date
- 05/03/2018
- Registration date
- 19/03/2018
- Last edited
- 10/09/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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)
Contact information
Scientific
Department of Anesthesiology, Faculty of Medicine and Health Sciences
University of Sherbrooke
3001 12th Avenue North
Sherbrooke
J1H 5N4
Canada
 ORCID ID |
0000-0003-1323-0449 |
|---|
Study information
| Study design | Single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Hemodynamic responses to tracheal intubation with Bonfils compared to C-MAC videolaryngoscope: a randomized trial |
| Study objectives | Intubation using Bonfils would increase mean arterial pressure and heart rate less than with C-MAC |
| Ethics approval(s) | Étienne Le Bel Clinical research Centre (Centre de recherche clinique Étienne-Le-Bel), 18/08/2014, ref:14-111 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2013 |
| Completion date | 25/01/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Elective surgery 2. Classified as American Society of Anesthesia (ASA) 1 or 2 2. Aged 18-60 years old. |
| Key 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. |
| Date of first enrolment | 01/09/2014 |
| Date of final enrolment | 23/08/2015 |
Locations
Countries of recruitment
- Canada
Study participating centre
Sherbrooke
J1H 5N4
Canada
Sponsor information
University/education
Department of Anesthesiology, Faculty of Medicine and Health Sciences
University of Sherbrooke
3001 12th Avenue North
Sherbrooke
J1H 5N4
Canada
| Phone | +1 819 821-8000 |
|---|---|
| Anesthesie-Med@USherbrooke.ca | |
"ROR" |
https://ror.org/00kybxq39 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Sherbrooke, UdeS, UDS
- Location
- Canada
Results and Publications
| Intention to publish date | 25/01/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 12/03/2018 | 26/03/2018 | No | No | |
| Results article | results | 07/09/2018 | Yes | No |
Additional files
- 34923_BasicResults_12Mar18.pdf
- Uploaded 26/03/2018
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.
