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Given the current Covid-19 pandemic alongside the lack of evidence on aerosolization during upper endoscopy the investigators are conducting a randomized controlled trial seeking to assess both the level of aerosolization that occurs during these procedures along with determining if utilization of an endoscopic patient face-masks reduces the level of aerosolized particles. The protocol includes the use of a commercially available particle counter the investigators are employing for the measurement of aerosols before, during, and after anesthesia assisted upper endoscopic procedures. The investigators are recruiting patients undergoing these procedures with a target of 30 patients undergoing endoscopy without a facemask and 30 patients undergoing endoscopy with one.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Facemask | Active Comparator | Patients undergoing endoscopy with the use of an endoscopic facemask |
|
| No Endoscopic Facemask | No Intervention | Patients undergoing endoscopy without an endoscopic facemask |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Patient Facemask | Device | A commonly used endoscopic patient facemask that is normally used for oxygen delivery during endoscopy will be tested in this trial as a potential intervention for decreasing particle aerosolization |
| Measure | Description | Time Frame |
|---|---|---|
| Aerosolization of Particles During Upper Endoscopy | Comparing the aerosolization of particles of six different sizes [0.3μm, 0.5μm, 1μm, 2μm, 5μm and 10μm] during endoscopy between patients using an endoscopic facemask to those without. | Start of endoscopy through the end of endoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Vargo, MD | Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endoscopic Facemask | Patients undergoing endoscopy with the use of an endoscopic facemask Endoscopic Patient Facemask: A commonly used endoscopic patient facemask that is normally used for oxygen delivery during endoscopy will be tested in this trial as a potential intervention for decreasing particle aerosolization |
| FG001 | No Endoscopic Facemask | Patients undergoing endoscopy without an endoscopic facemask |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endoscopic Facemask | Patients undergoing endoscopy with the use of an endoscopic facemask Endoscopic Patient Facemask: A commonly used endoscopic patient facemask that is normally used for oxygen delivery during endoscopy will be tested in this trial as a potential intervention for decreasing particle aerosolization |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aerosolization of Particles During Upper Endoscopy | Comparing the aerosolization of particles of six different sizes [0.3μm, 0.5μm, 1μm, 2μm, 5μm and 10μm] during endoscopy between patients using an endoscopic facemask to those without. | The data will be analyzed via stratification by particle size as a as a volumetric measurement of density: the number of particles per unit volume. | Posted | Least Squares Mean | 95% Confidence Interval | particle count per cubic ft | Start of endoscopy through the end of endoscopy |
|
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Adverse events were not collected for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endoscopic Facemask | Patients undergoing endoscopy with the use of an endoscopic facemask Endoscopic Patient Facemask: A commonly used endoscopic patient facemask that is normally used for oxygen delivery during endoscopy will be tested in this trial as a potential intervention for decreasing particle aerosolization |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Vargo | Cleveland Clinic Foundation | 2164455012 | vargoj@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2021 | Aug 23, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 21, 2022 | Mar 28, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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One group of patients will be randomly assigned to receive an endoscopic facemask and one group of patients will undergo endoscopy without a facemask.
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|
| No Endoscopic Facemask |
Patients undergoing endoscopy without an endoscopic facemask |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | No Endoscopic Facemask | Patients undergoing endoscopy without an endoscopic facemask |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | No Endoscopic Facemask | Patients undergoing endoscopy without an endoscopic facemask | 0 | 0 | 0 | 0 | 0 | 0 |
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