University Hospitals Leuven
Leuven, Flemish Brabant, 3000, Belgium
NCT Number: NCT04864015
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Leuven, Flemish Brabant, 3000, Belgium
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of a Mouthpiece B1 during standard EGD instead of a conventional mouthpiece
Time frame: 4 months
Number of aerosols generated by EGD with the droplet reduction mouthpiece
Universitaire Ziekenhuizen KU Leuven
Other
COVID-19: a Study About Aerosol Formation During Gastroscopy With a Adjusted Mouthpiece for Droplet Reduction
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04532112
Aerosol Disease, Droplet Spread
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT04518033
Droplet Spread
Boston, Massachusetts, United States
View Trial DetailsNCT04924881
COVID-19, Coronaviridae Infections
Shatin, Hong Kong
View Trial DetailsNCT04939506
Behavior, COVID-19
New Orleans, Louisiana, United States
View Trial Details