Taiwan "Aerosol Box" Versus UMMC "Intubation Box"

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04385576
• Other study ID #: 2020410-8498
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2020
• Source: University of Malaya
• Contact: SHAIRIL R RUSLAN, MAnaes(UM)
• Phone: +60123291074
• Email: shairil[@]ummc.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Airway
• COVID-19

Intervention

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.
• 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.

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

Canelli R, Connor CW, Gonzalez M, Nozari A, Ortega R. Barrier Enclosure during Endotracheal Intubation. N Engl J Med. 2020 Apr 3. doi: 10.1056/NEJMc2007589. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of intubation attempts	Number of attempts taken to successfully intubate the airway manikin	10 minutes
Secondary	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

External Links

•   Taiwanese doctor invents device to protect US doctors against coronavirus