COVID-19 Aerosol in EGD Using a Droplet Reduction Mouthpiece

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT04864015
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
3.4
Actual Duration (Months)
23.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A investigator-initiated single center open-label randomized trialA investigator-initiated single center open-label randomized trial
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
COVID-19: a Study About Aerosol Formation During Gastroscopy With a Adjusted Mouthpiece for Droplet Reduction
Actual Study Start Date :
Mar 17, 2021
Actual Primary Completion Date :
May 15, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

ArmIntervention/Treatment
Placebo Comparator: Conventional mouthpiece

Patients undergoing standard EGD using a conventional mouthpiece

Device: 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

Active Comparator: Droplet reduction mouthpiece

Patients undergoing standard EGD using a new droplet reduction mouthpiece

Device: 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

Outcome Measures

Primary Outcome Measures

  1. Generation of aerosol particles by esophagogastroduodenoscopy with the droplet reduction mouthpiece. [4 months]

    Number of aerosols generated by EGD with the droplet reduction mouthpiece

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University Hospitals LeuvenLeuvenFlemish BrabantBelgium3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

  • Principal Investigator: Jan Tack, MD, PhD, UZ Leuven, KU Leuven
  • Principal Investigator: Raf Bisschops, MD, PhD, UZ Leuven, KU Leuven

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT04864015
Other Study ID Numbers:
  • s65197
First Posted:
Apr 28, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universitaire Ziekenhuizen Leuven
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021