COVID Clinical Trial
Official title:
COVID-19 Serologic Screening and a Strict Protocol in the Management of a Referral Gastrointestinal Endoscopy Unit: a Prospective Study
The novel COronaVIrus Disease 19 (COVID-19) outbreak has impacted daily activities in nearly
210 countries and territories worldwide. In Ecuador, the city of Guayaquil has nearly
two-thirds of the COVID-positive patients in the country and nearly 40% of infected
individuals are health-care related personnel.
Nonemergent, emergent and urgent endoscopic procedures are necessary to be performed during
the COVID-19 pandemic. Several experiences in the management of the endoscopic unit during
the pandemic has been proposed. We aimed to prospectively evaluate a strict protocol for
preventing potential nosocomial infection of COVID-19.
Consecutive patients with appointment for endoscopic examination and procedures will be
contacted via a telephone call by a pulmonologist, who will perform a triage with a screening
questionnaire between 24-48 hours before the scheduled procedure. The pulmonologist will seek
for history of fever, respiratory symptoms, and/or close-contacts COVID-patients. After
exclusion of all respiratory symptoms or history suggestive of COVID-19, patients will be
evaluated for serum IgG and IgM levels using a rapid test.
Only after complete evaluation and revision of serological levels, body temperature will be
measure before entering the endoscopy unit. Patients will be isolated in an individual
preoperative and recovery room after the endoscopic procedure, avoiding contacts with other
patients. The endoscopy staff (endoscopists, nurses, administrative personal, anesthesia
staff) will use personal protective equipment (PPE) including N95 face mask, face shield,
shoe covers, gowns, and gloves.
All the staff will be evaluated for nucleic acid PCR testing within three days before
resuming activities in the endoscopy unit, all staff members will be evaluated for
respiratory symptoms and changes in body temperature before starting daily activities. At the
end of the study all the staff will be evaluated for IgM and IgG antibodies against COVID-19.
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