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
- 1
- 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
研究组 & 干预措施
Control group
Usual care will be provide to patients concerning their medical management.
In the Control Group usual, oxygen will be delivered as per usual local practices
干预措施: Standard administration of oxygen flow (Other)
Intervention group
Usual care will be provide to patients concerning their medical management.
In the Intervention group, automated oxygen administration will be delivered with FreeO2
干预措施: Automated oxygen administration - FreeO2 (Device)
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
- 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 ICU admission(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))