COVID-19 Serologic Screening and a Strict Protocol in the Management of a Referral Gastrointestinal Endoscopy Unit: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Numbers of patients evaluated and treated during the COVID-19 outbreak in the endoscopy unit at the end of the 30-days study.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing to participate
- •Available serum samples for IgG and IgG antibodies against COVID-19
- •Ability to complete the screening questionnaire
排除标准
- •Patients with respiratory symptoms
- •Patients with COVID-19 active infection
结局指标
主要结局
Numbers of patients evaluated and treated during the COVID-19 outbreak in the endoscopy unit at the end of the 30-days study.
时间窗: through study completion, an average 30 days
Endoscopic records of patients treated during the COVID-19 protocol
Rate of COVID-19 nosocomial infection among the endoscopy staff at the end of the 30-days study.
时间窗: through study completion, an average of 30 days
COVID-19 infection in the staff documented via PCR
Technical success rate of endoscopic procedures during the 30-days study period.
时间窗: through study completion, an average 30 days
technical success of endoscopic procedures
IgG and IgM against COVID-19 in the endoscopy staff measured at the end of the study.
时间窗: through study completion, an average 30 days
serum levels of IgG and IgM against COVID-19
Adverse events rate of endoscopic procedures during the 30-days
时间窗: through study completion, an average 30 days
adverse events of endoscopic procedures
次要结局
未报告次要终点