Automated Oxygen Titration - Monitoring and Weaning in Patients With Infectious Pneumonia Requiring Oxygen - Impact on the Number of Interventions for Healthcare Workers. An Innovative Device to Manage Patients With COVID-19 Pneumonia COVID Study (Closed-Loop Oxygen to Verify That Healthcare Workers Interventions Decreaseduring Pneumonia)
试验速览
- 阶段
- 不适用
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- The number of interventions
研究概览
简要总结
There is a high risk of transmission of COVID-19 to healthcare workers. In a recent cohort, 29% of the patients hospitalized were healthcare workers. Among the WHO's primary strategic objectives for the response to COVID-19, the first was to limit human-to-human transmission, including reducing secondary infections among close contacts and health care workers.
Automated oxygen titration, weaning and monitoring (FreeO2 device) may be a solution to reduce the number of interventions of healthcare workers related to oxygen therapy, to reduce complications related to oxygen and to improve monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years old
- •patients with acute respiratory failure related to suspected community acquired pneumonia (viral and non viral) requiring oxygen therapy < 6 L/min (or FiO2< 0.50) (to maintain SpO2 between 90 and 94% SpO2) without criteria for immediate intubation or ICU transfer.
- •Patients hospital admission < 72 hours
排除标准
- •shock state,
- •no SpO2 signal available,
- •patient agitation,
- •pH < 7.30 (if blood gas available)
- •PaCO2 > 50 mmHg, (if blood gas available) or chronic hypercapnia history
- •Non invasive respiratory support (NIV, High flow Nasal Therapy (HFNT)) at study inclusion
- •Withdrawal of life support or palliation as the goal of care
- •patients' or next of kin refusal to participate to the study
结局指标
主要结局
The number of interventions
时间窗: Hour0 to Hour4
The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
Duration of interventions
时间窗: Hour0 to Hour24
The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
次要结局
- Rate of ICU admission(Hour0 to Hour24 (1 day))
- Time with hyperoxemia(Hour0 to Hour24 (1 day))
- Time with hypoxemia(Hour0 to Hour24 (1 day))
- EWSO2 score evolution(Hour0 to Hour24 (1 day))
- Time within theSpO2 target(Hour0 to Hour24 (1 day))
- Rate of intubation(Hour0 to Hour24 (1 day))
- Mean oxygen flow(Hour0 to Hour24 (1 day))
- Rate of needed non invasive respiratory support(Hour0 to Hour24 (1 day))
- Cost-effectiveness(From date of randomization until the date of hospital discharge)
- length of stay(up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured)
- NEWS 2 score evolution(Hour0 to Hour24 (1 day))