Clinical trial NCT04371354: Outcomes of Covid-19 Protective Measures in Endoscopy
Official title: Outcomes After Implementation of a Protective Protocol for Covid-19 in Large Spanish Endoscopy Units.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19 Disease
Endoscopy Unit
Keywords: Covid-19 disease
endoscopy
gastrointestinal
personal protective equipment
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing an endoscopic procedure

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of new Covid infection of patients and staff members
timeFrame: 3 months
Secondary outcomes:
measure: Covid disease prevalence in the patients referred to endoscopy
timeFrame: 3 months
measure: Categorization by clinical triage and Covid Test
timeFrame: 3 months
measure: Type of endoscopy procedure and staff protective equipment
timeFrame: 3 months
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
Study officials:
affiliation: Tertiary referral hospital: Complejo Hospitalario de Navarra. Pamplona.Spain
name: Juan J Vila, PhD
role: PRINCIPAL_INVESTIGATOR
References: