Evaluation of Transnasal Endoscopy During COVID-19 Pandemic
Primary Purpose
Endoscopy
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
gastroscopy in transnasal techique
Sponsored by
About this trial
This is an interventional supportive care trial for Endoscopy focused on measuring gastroscopy, transnasal, nursing
Eligibility Criteria
Inclusion Criteria:
- Indication for transnasal endoscopy
Exclusion Criteria:
- pregnancy
- breast feeding
- contraindication to transnasal endoscopy
- pronounced blood clotting disorders
Sites / Locations
- University Hospital MainzRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Gastroscopy in transnasal technique
Arm Description
All patients with indication for gastroscopy in transnasal techqiue are included.
Outcomes
Primary Outcome Measures
Questionnaire
a questionnaire with 5 questions regarding the quality of the examination, technique and safety is presented to the patients
Secondary Outcome Measures
Full Information
NCT ID
NCT04734912
First Posted
January 13, 2021
Last Updated
January 30, 2021
Sponsor
Johannes Gutenberg University Mainz
1. Study Identification
Unique Protocol Identification Number
NCT04734912
Brief Title
Evaluation of Transnasal Endoscopy During COVID-19 Pandemic
Official Title
Evaluation of Transnasal Endoscopy During COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
June 15, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients who received the indication for endoscopic diagnostics using gastroscopy in transnasal technique will be included into the study. The examination is carried out in standard technique and is not influenced by the study. Following the examination, patient data is collected pseudonymously and a questionnaire is submitted to the patient.
Detailed Description
COVID-19 is transmitted, among other things, by a droplet infection. Conventional gastroscopy through the patient's mouth is therefore considered a high-risk examination for the medical and nursing staff. Alternatively, gastroscopy can also be performed through the patient's nose. An advantage here is that the aerosol formation is naturally significantly reduced and the patient usually does not need sedation, since in transnasal endoscopy no stranglehold occurs. Transnasal endoscopy therefore appears to us, especially during the COVID-19 pandemic, as a safe alternative to conventional gastroscopy.
Patients who received the indication for endoscopic diagnostics using gastroscopy in transnasal technique will be included into the study. The examination is carried out in standard technique and is not influenced by the study. Following the examination, patient data is collected pseudonymously and a questionnaire is sumbitted to the patient.
Only patients who have the indication for gastroscopy in transnasal technique are included. A specific risk to patients cannot be foreseen.This study does not interfere with diagnostics or therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopy
Keywords
gastroscopy, transnasal, nursing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all patients with indication für gastroscopy in transnasal techique are included.
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gastroscopy in transnasal technique
Arm Type
Other
Arm Description
All patients with indication for gastroscopy in transnasal techqiue are included.
Intervention Type
Other
Intervention Name(s)
gastroscopy in transnasal techique
Intervention Description
All patients with indication for gastroscopy in transnasal technique are included.
Primary Outcome Measure Information:
Title
Questionnaire
Description
a questionnaire with 5 questions regarding the quality of the examination, technique and safety is presented to the patients
Time Frame
after examination, about 15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Indication for transnasal endoscopy
Exclusion Criteria:
pregnancy
breast feeding
contraindication to transnasal endoscopy
pronounced blood clotting disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helmut Neumann, M.D. PhD
Phone
+49 (0) 6131
Ext
176838
Email
helmut.neumann@unimedizin-mainz.de
First Name & Middle Initial & Last Name or Official Title & Degree
Tanja Bender, M.A.
Phone
+49 (0) 6131
Ext
176838
Email
tanja.bender@unimedizin-mainz.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Neumann, M.D. PhD
Organizational Affiliation
University Medical Center Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Mainz
City
Mainz
State/Province
Rhenanie-Palatinate
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Helmut Neumann, M.D. PhD
Phone
+49 (0) 6131
Ext
176838
Email
helmut.neumann@unimedizin-mainz.de
First Name & Middle Initial & Last Name & Degree
Tanja Bender, M.A:
Phone
+49 (0) 6131
Ext
176838
Email
tanja.bender@unimedizin-mainz.de
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
A publication of the results is planned.
Learn more about this trial
Evaluation of Transnasal Endoscopy During COVID-19 Pandemic
We'll reach out to this number within 24 hrs