Skip to main content
Clinical Trials/NCT04371354
NCT04371354UnknownNot Applicable

Outcomes After Implementation of a Protective Protocol for Covid-19 in Large Spanish Endoscopy Units.

Fundacion Miguel Servet1 site in 1 country100 target enrollmentStarted: April 27, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Rate of new Covid infection of patients and staff members

Study Overview

Brief Summary

Prospective study evaluating the outcomes of implementation of a protective protocol for Covid-19 for patients and staff in a large endoscopy unit.

Detailed Description

Detailed description: SARS-Covid-19 virus pandemic has had a big impact both socially and on operation of health facilities. During the Covid-19 outbreak most of the scheduled endoscopies were cancelled and only emergent and urgent endoscopies were performed in the unit. This meant that for six weeks, around 98% of our daily workload was cancelled. During that time the investigators have developed a protocol in order to resume scheduled endoscopic activity in the decreasing phase of the pandemic.

The hypothesis of this prospective observational study is that implementation of a protocol based upon Covid PCR tests and clinical triage is useful to categorize two types of Covid-19 infection risk and two levels of personal protection equipments required.

The primary aim is to evaluate the outcomes of implementing a protective protocol with two levels of protection for Covid-19 in the endoscopy unit. As secondary aims, the investigators, want to evaluate the endoscopy unit staff and patients infection rate after implementation of the protective protocol; and the utility of previous Covid PCR testing and on day clinical triage to discriminate patients before endoscopy.

A brief daily questionnaire will be filled by all the endoscopy unit staff members questioning about type of procedures performed in their allocated endoscopy room, level of protection used and PCR status of their attended patients. Patients will be followed up for a period of two weeks to discard development of Covid-19 disease with possible origin in their visit to the endoscopy unit.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients undergoing an endoscopic procedure with written informed consent given.
  • Staff allocated in the endoscopy unit.

Exclusion Criteria

  • Refection to participate in the study.

Outcomes

Primary Outcomes

Rate of new Covid infection of patients and staff members

Time Frame: 3 months

Number of new Covid infection of patients and staff members

Secondary Outcomes

  • Type of endoscopy procedure and staff protective equipment(3 months)
  • Covid disease prevalence in the patients referred to endoscopy(3 months)
  • Categorization by clinical triage and Covid Test(3 months)

Investigators

Sponsor
Fundacion Miguel Servet
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Juan J Vila, MD, PhD

medical doctor, University of Navarra associate professor

Fundacion Miguel Servet

Study Sites (1)

Loading locations...

Similar Trials

Outcomes of Covid-19 Protective Measures... | Clinical Trial