COVID-19 Aerosol in EGD Using a Droplet Reduction Mouthpiece

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Covid19; Droplet Spread

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04864015

s65197

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

Conventional mouthpiece

Placebo Comparator group

Description:

Patients undergoing standard EGD using a conventional mouthpiece

Treatment:

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

Droplet reduction mouthpiece

Active Comparator group

Description:

Patients undergoing standard EGD using a new droplet reduction mouthpiece

Treatment:

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