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

NCT04865081 | Unknown

• 1 other identifier: 20212465
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation

Keywords

videolaryngoscopy; intubation box; aerosol box; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Success rate of intubation at first laryngoscopy

  Immediately after the intubation

• Ease of tracheal intubation

  Immediately after the intubation

• VACCIN box installation time

  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

  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

  Immediately after the intubation

Study Arms (2)

VACCIN box group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Enrolled participants in the control group will be intubated without the use of the VACCIN intubation box (standard anesthesia).

Interventions

VACCIN box DEVICE

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.

VACCIN box group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Maisonneuve Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Issam Tanoubi

CONTACT

514 252 3400; i.tanoubi@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MA(ed), Associate Professor

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 29, 2021
• Study Start: April 19, 2021
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)