COVID-19 Aerosol in EGD Using a Droplet Reduction Mouthpiece

NCT ID: NCT04864015

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2021-06-30

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

Conditions

Droplet Spread; Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Conventional mouthpiece

Patients undergoing standard EGD using a conventional mouthpiece

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DEVICE

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

Droplet reduction mouthpiece

Patients undergoing standard EGD using a new droplet reduction mouthpiece

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

Mouthpiece 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Tack, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven, KU Leuven

Raf Bisschops, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven, KU Leuven

Locations

University Hospitals Leuven

Leuven, Flemish Brabant, Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

s65197

Identifier Type: -

Identifier Source: org_study_id