NCT04385576

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

April 28, 2020

Last Update Submit

May 7, 2020

Conditions

COVID-19Airway

Keywords

intubation boxCOVID-19personnel protective equipment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of intubation attempts

    10 minutes

  • Evaluation of the intubator's experience using both boxes

    10 minutes

Study Arms (2)

Aerosol Box

ACTIVE COMPARATOR

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

Device: Aerosol BoxDevice: Intubation Box

Intubation Box

ACTIVE COMPARATOR

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

Device: Aerosol BoxDevice: Intubation Box

Interventions

Aerosol BoxDEVICE

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.

Aerosol BoxIntubation Box
Intubation BoxDEVICE

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.

Aerosol BoxIntubation Box

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Selangor, 59100, Malaysia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32243118RESULT

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • INA I SHARIFFUDDIN, MAnaes

    University of Malaya

    STUDY DIRECTOR

Central Study Contacts

SHAIRIL R RUSLAN, MAnaes(UM)

CONTACT

+60123291074shairil@ummc.edu.my

MOHD F ZAINAL ABIDIN, MAnaes

CONTACT

+60162823181m.fitry@ummc.edu.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 13, 2020

Study Start

May 15, 2020

Primary Completion

September 15, 2020

Study Completion

December 30, 2020

Last Updated

May 13, 2020

Record last verified: 2020-05

Locations

MY(1)