Clinical Evaluation of an Aerosol Protective Intubation Device on Videolaryngoscopic Intubation Difficulty

First Randomised Controlled Clinical Evaluation of the Impact of Anti-Aerosol VACCIN Box on the Videolaryngoscopic Intubation Procedure

The VACCIN box, an anti-aerosol intubation box for potential use on COVID-19 (SARS-CoV-2) positive patients, was designed in order to reduce the transmission risk to healthcare workers. This study will compare the safety and the ease of use of the VACCIN box to a standard intubation in healthy participants undergoing elective surgery. It is expected that intubation times and success rate of intubation in the same circumstances will be similar with and without the use of the VACCIN box.

Study Overview

• Status: Recruiting
• Conditions: Intubation
• Intervention / Treatment: Device: VACCIN box

Detailed Description

Novel ways to protect healthcare workers were developed around the world in the setting of the COVID-19 (SARS-CoV-2) pandemic. Shortage of personal protective equipment (PPE) and concern of potential viral transmission during aerosol generating procedures such as endotracheal intubation fueled the emergence of intubation boxes. However, a lack of details about their safety and efficiency remains.

This study will evaluate safety and ease of use of the VACCIN box in participants undergoing elective surgery requiring endotracheal intubation. The study design is a prospective randomized single center clinical trial comparing intubation with and without its use. It is expected that intubation times and success rate of intubation in the same circumstances will be similar with and without the use of the VACCIN box. Eligible participants will be randomized in a 1:1 ratio after informed consent.

Participants in both groups will be intubated in the same circumstances. The procedure include a midazolam anxiolysis, a rapid sequence induction without cricoid pressure of predefined dosing of remifentanil, propofol and rocuronium and monitoring of an adequate muscles paralysis and dept of anesthesia.

Anesthesiologists will intubate in both groups using specific material: McGRATH videolaryngoscope with X-Blade, 8 mm endotracheal tube (ETT) for men or 7 mm for women and the Glidescope videolaryngoscope stylet inside the ETT.

The experimental group will differ from the control group by application of the VACCIN box over the participant's head through which the anesthesiologist will intubate. Proper installation and removal of the VACCIN box will also be evaluated.

Intubations will only be done by anesthesiologists to assure patient safety. Each anesthesiologist will be assigned a practice session using the VACCIN box on an intubation mannequin prior to the study.

Time measurements throughout the procedure will be taken to obtain the outcomes measures. Vital signs, TOF, NOL index and BISpectral index monitoring are part of the protocol in order to assure an adequate anesthesia induction prior and after intubation.

A total of 60 participants will be enrolled in the study (30 in each group). Sample size calculation was based on local intubation mean time with COVID-19 pandemic protocols of 45 seconds with a 15 seconds standard deviation (SD). 26 participants per group are needed considering that an intubation time that is 30% or more over the current mean would imply that the VACCIN Box slowed down the intubation with an assumed SD of 15 seconds, a significance level of 5% and power of 90%. Sample size per group was rounded up to 30 in order to overcome possible exclusion or loss.

The primary outcome, the intubation time in seconds, will be tested for normal distribution with a D'Agostino-Pearson omnibus normality test and analyzed using a Two-tailed Student t test for unpaired groups. The intubation time will be presented as mean and standard deviation [SD].

For the secondary outcomes, the χ2 test will be used for the comparisons of the success rate of intubation at first laryngoscopy. The Mann-Whitney U test will be used to compare the ease of intubation.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Issam Tanoubi; Phone Number: 3426 514 252 3400; Email: i.tanoubi@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • Maisonneuve Rosemont Hospital
      • Contact: Issam Tanoubi, MD; Phone Number: 3426 514 252 3400; Email: i.tanoubi@umontreal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective surgery requiring general anesthesia with tracheal intubation
• ASA status I, II or III
• Good understanding of English or French

Exclusion Criteria:

• Known difficult airway
• Anticipated difficult airway (Mallampati ≥ 3, oral opening < 2.5 cm, thyromental distance < 6 cm, limited cervical mobility, significant abnormality of the upper respiratory tract, history of major surgery on airway or cervical area)
• COVID-19 positive or unknown status
• Rapid sequence contraindication
• Presence of antibiotic-resistant bacteria requiring a form of additional protective equipment
• Claustrophobia
• Chronic anxiety
• BMI ≥ 35
• Allergy or intolerance to any of the study drugs
• Emergent surgery
• Pregnancy
• Preoperative hemodynamic disturbance
• Patient refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VACCIN box group; The anesthesiologist will intubate the participants in the VACCIN box group while using the VACCIN box that will be placed over the participants' head.	Device: VACCIN box; The VACCIN box is a translucid box that can be placed over the patient's head. It has entry holes on the front and the side of the box in which nitrile gloves can be attached. The anesthesiologist can intubate with arms and hands inside the box. Its also has the capacity to create a negative pressure environment inside the box by connecting an air suction cable from the box to the OR medical aspiration line.
NO_INTERVENTION: Control group; Enrolled participants in the control group will be intubated without the use of the VACCIN intubation box (standard anesthesia).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time	Seconds	Intubation time will correspond to the time interval in seconds between the preoxygenation face mask removal and the detection of end-tidal CO2 on the anesthesia monitor

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of intubation at first laryngoscopy	Percentage	Immediately after the intubation
Ease of tracheal intubation	Numeric scale of 0 to 10	Immediately after the intubation
VACCIN box installation time	Seconds	The VACCIN box installation time will correspond to the time interval in the experimental group between the start of the VACCIN box placement over the participant's head to the removal of the preoxygenation mask before intubation.
VACCIN box removal time	Seconds	The VACCIN box removal time will correspond to the time interval in the experimental group between the initial detection of end-tidal CO2 on the anesthesia monitor to the complete removal of the VACCIN box.
Breach of air tightness	Percentage	Immediately after the intubation
Qualitative reviews on intubation with the VACCIN box	Qualitative	Immediately after the intubation
Non-invasive blood pressure variations around tracheal intubation	mmHg	before, during and for 5 minutes after tracheal intubation
Heart rate variations around tracheal intubation	bpm	before, during and for 5 minutes after tracheal intubation
NOL variation (NOL is an index without unit) around tracheal intubation	Varies from 0 to 100, no unit	before, during and for 5 minutes after tracheal intubation
Bispectral index (BIS) variation (BIS is an index without unit) around tracheal intubation	Varies from 0 to 100, no unit	before, during and for 5 minutes after tracheal intubation

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2021
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (ACTUAL): April 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; videolaryngoscopy; aerosol box; intubation box
• Other Study ID Numbers: 20212465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No