Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864015
Status:
COMPLETED
Last Update Posted:
2021-10-08
First Post:
2021-04-27
Brief Title:
COVID-19 Aerosol in EGD Using a Droplet Reduction Mouthpiece
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
COVID-19 a Study About Aerosol Formation During Gastroscopy With a Adjusted Mouthpiece for Droplet Reduction
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 GMDN62534 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None