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Taiwan "Aerosol Box" Versus UMMC "Intubation Box"

Primary Purpose

COVID-19, Airway

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Aerosol Box
Intubation Box
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COVID-19 focused on measuring intubation box, COVID-19, personnel protective equipment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Malaya Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aerosol Box

Intubation Box

Arm Description

Intubation using the Taiwan model Aerosol Box to assess the duration of time needed for successful endotracheal intubation of an airway manikin.

Intubation using the UMMC model Intubation Box to assess the duration of time needed for successful endotracheal intubation of an airway manikin.

Outcomes

Primary Outcome Measures

Time to successful intubation
The interval from insertion of the laryngoscope blade into the mouth to inflation of the tracheal tube cuff

Secondary Outcome Measures

Number of intubation attempts
Number of attempts taken to successfully intubate the airway manikin
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.

Full Information

First Posted
April 28, 2020
Last Updated
May 7, 2020
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT04385576
Brief Title
Taiwan "Aerosol Box" Versus UMMC "Intubation Box"
Official Title
Taiwan "Aerosol Box" Versus UMMC "Intubation Box" : Clinical Evaluation of the "Intubation Box" for Ease of Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2020 (Anticipated)
Primary Completion Date
September 15, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Airway
Keywords
intubation box, COVID-19, personnel protective equipment

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerosol Box
Arm Type
Active Comparator
Arm Description
Intubation using the Taiwan model Aerosol Box to assess the duration of time needed for successful endotracheal intubation of an airway manikin.
Arm Title
Intubation Box
Arm Type
Active Comparator
Arm Description
Intubation using the UMMC model Intubation Box to assess the duration of time needed for successful endotracheal intubation of an airway manikin.
Intervention Type
Device
Intervention Name(s)
Aerosol Box
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Intubation Box
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to successful intubation
Description
The interval from insertion of the laryngoscope blade into the mouth to inflation of the tracheal tube cuff
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Number of intubation attempts
Description
Number of attempts taken to successfully intubate the airway manikin
Time Frame
10 minutes
Title
Evaluation of the intubator's experience using both boxes
Description
Evaluation of the intubator's experience using both boxes using a questionnaire based on the ISO9421-11 standard, that is effectiveness, efficiency and satisfaction.
Time Frame
10 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SHAIRIL R RUSLAN, MAnaes(UM)
Phone
+60123291074
Email
shairil@ummc.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
MOHD F ZAINAL ABIDIN, MAnaes
Phone
+60162823181
Email
m.fitry@ummc.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
INA I SHARIFFUDDIN, MAnaes
Organizational Affiliation
University of Malaya
Official's Role
Study Director
Facility Information:
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
State/Province
Selangor
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SHAIRIL R RUSLAN, MAnaes(UM)
Phone
0123291074
Email
shairil@ummc.edu.my

12. IPD Sharing Statement

Citations:
PubMed Identifier
32243118
Citation
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.
Results Reference
result
Links:
URL
https://www.taiwannews.com.tw/en/news/3902435
Description
Taiwanese doctor invents device to protect US doctors against coronavirus

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Taiwan "Aerosol Box" Versus UMMC "Intubation Box"

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