Taiwan "Aerosol Box" Versus UMMC "Intubation Box"

Taiwan "Aerosol Box" Versus UMMC "Intubation Box" : Clinical Evaluation of the "Intubation Box" for Ease of Intubation

This study compares two intubation boxes, that is the Taiwan "Aerosol Box" versus the UMMC "Intubation Box". The importance of this intubation box has come to light recently in view of the COVID-19 pandemic and the fact that intubation is an aerosol-generating procedure. Risks of the healthcare worker attending to the airway of COVID-19 patients is high and the intubation box aims to minimize that and reduce contamination of the environment. The original design of the "Aerosol Box" has limitations and is not easily used by intubators. This study evaluates the clinical usefulness of an innovation of the "Aerosol Box" design that is made to be more ergonomic and increases the rate of successful intubation. Anaesthetists with more than 5 years of clinical experience in intubating airways as well as more than 20 successful intubations using videolaryngoscopy , will be available to participate. This study will employ manikin and will be a randomized cross-over trial, conducted in UM.

Study Overview

• Status: Unknown
• Conditions: COVID-19; Airway
• Intervention / Treatment: Device: Aerosol Box; Device: Intubation Box

Detailed Description

Background:

Intubation is classified as an aerosol-generating procedure (AGP). Intubation in a confirmed COVID-19 patient with a high viral load poses a high risk of exposure to health care workers (HCW). To reduce this risk, the HCW and their assistants are advised to don full personnel protective equipment (PPE) with a powered air purifying respiratory (PAPR) during intubation. In view of this concern, this procedure is highly recommended to be done in a negative pressure room to control the spread of aerosolizing particles in the room. A first-pass success in intubation is also crucial to minimize the risk of infection to health care workers involved.

Introduction :

An Aerosol Box (from here on known as Box A) was recently designed by Dr. Lai Hsien Yung from Taiwan which adds extra protection to the intubator and the surrounding environment. The Aerosol Box is a transparent box made of acrylic or transparent polycarbonate sheet, designed with an opening on one side allowing it to fit over the patient's chest and neck, while the opposing side has two holes through which the intubator can insert their hands through. It was shown that this barrier enclosure during intubation protects the laryngoscopist. A recent study simulated a patient with a cough during intubation with and without the Aerosol Box. With the box, it was demonstrated that the simulated cough resulted in contamination of only the inner surface of the box, the laryngoscopist's gloves and gowned forearms. Examination of the laryngoscopist and the room with ultraviolet light after the simulated cough also showed no macroscopic contamination outside the box. In contrast, intubation without the box demonstrated that the laryngoscopist's gown, gloves, face mask, eye shield, hair, neck, ears, and shoes were all contaminated.

Feedbacks from our colleagues stated that intubation with Box A is slightly difficult and may cause delay in intubation. Canelli et al also concluded this observation. The investigators, therefore, innovated the design of Box A to facilitate the laryngoscopist, known as the UMMC Intubation Box (from here on known as Box B).

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Kuala Lumpur, Selangor, Malaysia, 59100
      • Recruiting
      • University Malaya Medical Centre
      • Contact: SHAIRIL R RUSLAN, MAnaes(UM); Phone Number: 0123291074; Email: shairil@ummc.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• anaesthetists with more than 5 years of clinical experience AND more than 20 successful intubations using a videolaryngoscope

Exclusion Criteria:

• anaesthetists with less than 5 years of clinical experience AND/OR less than 20 successful intubations using a videolaryngoscope

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aerosol Box; Intubation using the Taiwan model Aerosol Box to assess the duration of time needed for successful endotracheal intubation of an airway manikin.	Device: Aerosol Box; Usage of an Intubation Box to minimize intubator and environment contamination during intubation and extubation. Time taken for first-pass success if also expected to be reduced with the usage of the Intubation Box.; Device: Intubation Box; Usage of an Intubation Box to minimize intubator and environment contamination during intubation and extubation. Time taken for first-pass success if also expected to be reduced with the usage of the Intubation Box.
Active Comparator: Intubation Box; Intubation using the UMMC model Intubation Box to assess the duration of time needed for successful endotracheal intubation of an airway manikin.	Device: Aerosol Box; Usage of an Intubation Box to minimize intubator and environment contamination during intubation and extubation. Time taken for first-pass success if also expected to be reduced with the usage of the Intubation Box.; Device: Intubation Box; Usage of an Intubation Box to minimize intubator and environment contamination during intubation and extubation. Time taken for first-pass success if also expected to be reduced with the usage of the Intubation Box.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to successful intubation	The interval from insertion of the laryngoscope blade into the mouth to inflation of the tracheal tube cuff	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intubation attempts	Number of attempts taken to successfully intubate the airway manikin	10 minutes
Evaluation of the intubator's experience using both boxes	Evaluation of the intubator's experience using both boxes using a questionnaire based on the ISO9421-11 standard, that is effectiveness, efficiency and satisfaction.	10 minutes

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Study Director: INA I SHARIFFUDDIN, MAnaes, University of Malaya

Publications and helpful links

General Publications

• Canelli R, Connor CW, Gonzalez M, Nozari A, Ortega R. Barrier Enclosure during Endotracheal Intubation. N Engl J Med. 2020 May 14;382(20):1957-1958. doi: 10.1056/NEJMc2007589. Epub 2020 Apr 3. No abstract available.

Helpful Links

• Taiwanese doctor invents device to protect US doctors against coronavirus

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2020
• Primary Completion (Anticipated): September 15, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; intubation box; personnel protective equipment
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020410-8498

Drug and device information, study documents

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