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COVID-19 Aerosol in EGD Using a Droplet Reduction Mouthpiece

COVID-19: a Study About Aerosol Formation During Gastroscopy With a Adjusted Mouthpiece for Droplet Reduction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04864015
Enrollment
80
Registered
2021-04-28
Start date
2021-03-17
Completion date
2021-06-30
Last updated
2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Droplet Spread

Keywords

droplet reduction mask, COVID-19, upper GI endoscopy

Brief summary

Measurement of aerosolisation during esophagogastroduodenoscopy (EGD) to compare two types of mouthpieces, conventional versus a new and commercially available one 'the droplet reduction mouthpiece B1'. This new mouthpiece is considered to reduce droplet spreading during EGD and therefore could be a good option for use in COVID-19 positive patients.

Detailed description

During esophagogastroduodenoscopy (EGD), a hard-plastic mouthpiece is used to protect the endoscope from being bitten and to enable its smooth insertion. In September 2020, the droplet reduction Mouthpiece B1 (Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable) was launched by Fujifilm Corporation, Tokyo, Japan and imported to Europe by Fujifilm Europe. The droplet reduction mouthpiece is used in the same way as the conventional mouthpiece but differs from current mouthpieces by the inclusion of a sponge rubber incorporated into the mouthpiece orifice, and a drape shield specifically created to catch and reduce the droplets emitted by the patient during upper gastrointestinal endoscopy. This newly developed mouthpiece is considered for application during routine endoscopy at our facility during the COVID-19 pandemic, helping to minimize the risk to health care workers and patients from becoming infected with COVID-19 and various other pathogens. However, there is a lack of scientific evidence on the amount of aerosol reduction with the modified mouthpiece when upper gastrointestinal (GI) endoscopy is being performed. The aim of the present study is to quantify the generation of aerosols when performing upper GI endoscopy with the modified mouthpiece. The investigators intend to quantify the number of particles in the air near the patient. The duration of therapeutic upper gastrointestinal endoscopies can vary extremely. To avoid risk of imbalance in procedure durations, the investigational team is limiting the protocol to standard diagnostic EGDs. The investigators assume that aerosol generations during short procedures can be extrapolated to longer procedures and hence this should not invalidate the findings

Interventions

DEVICEMouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable

Use of a Mouthpiece B1 during standard EGD instead of a conventional mouthpiece

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

A investigator-initiated single center open-label randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Aged \>18 years old; * Male or female patients; * Patients undergoing elective standard diagnostic EGD; * Negative polymerase chain reaction (PCR) test on nasopharyngeal swab 24 or 48 hours prior to the test; * No anatomical deformity of nose and throat, no known diseases of nose and throat; * Signed informed consent

Exclusion criteria

* Females who are pregnant or lactating.

Design outcomes

Primary

MeasureTime frameDescription
Generation of aerosol particles by esophagogastroduodenoscopy with the droplet reduction mouthpiece.4 monthsNumber of aerosols generated by EGD with the droplet reduction mouthpiece

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026