Interest of Respiratory Tele Monitoring in COVID-19 Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- respiratory degradation event 1
研究概览
简要总结
The determinants of the evolution to a severe form for COVID-19 pneumonia remain unclear. COVID-19 pneumonia is characterized by a hypoxemia with a possible rapid worsening and related resuscitation requirement. The monitoring of patients in hospital wards (excluding intensive care unit) is therefore both necessary and complicated given the contagious risks for health workers.
The COVID 19 Respiratory Tele Monitoring (RTM COVID 19) research project is based on a comparison between usual nurse respiratory monitoring (4 to 6 time per day) of respiratory parameters (capillary oxygen saturation, respiratory rate, hearth rate) and a continuous monitoring of these respiratory parameters with continuous monitoring by a portable, wireless and stand-alone device.
The main objective of this work is a more sensitive and earlier detection of respiratory degradation events in patients with COVID-19 pneumonia (capillary desaturation, increased respiratory rate) requiring the introduction of oxygen therapy, its increase or a resuscitation requirement with possible intensive care admission.
A prospective, randomized, multicentre, comparative exposure study will be conducted with planned inclusion of 80 patients. This investigation will focus on patients with COVID-19 pneumonia hospitalized in dedicated medical wards of two University Hospitals in France.
A randomization will be stratified by Hospital and adapted so that each Hospital provides the same number of subjects in each arms:
- Control Respiratory Monitoring Group (40 patients)
- Experimental Respiratory Monitoring Group (40 patients)
The main criterion is respiratory degradation event, during a 4 days period after ward admission, which motivates a change in the therapeutic strategy defined by the presence of at least one of these elements:
- Capillary saturation < 94% (regardless of oxygen intake) for at least 2 minutes.
- And/or an increase in respiratory rate > 20/minute for at least 2 minutes.
The modification of the therapeutic strategy is defined by:
- Introduction of oxygen therapy for included patients without oxygen therapy or supplementation of oxygen therapy > 2 litres/minutes for included patients with oxygen therapy
- And/or introduction of a high oxygen concentration mask
- And/or Request an On-Site Opinion from a member of the resuscitation team.
- And/or Transfer to intensive care or resuscitation unit
- And/or Need for immediate resuscitation for life-threatening distress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with COVID 19 pneumonia assessed by PCR and CT scann.
- •Patient admited in a dedicated medical ward
- •Patient with oxygen supply less or equal to 4 liters per minute.
- •Written informed consent
排除标准
- •Patient with limitation of care.
- •Patient with immediate risk to ICU transfer within the first 12 hours
- •Patient with neurological or psychiatric symptoms that interfere with respiratory parameters interpretation.
- •Patient with acute or chronic respiratory disease such as COPD, cancer.
- •Pregnancy, age < 18 of vulnerable profile.
- •Patient refusal to participate or previously included in a clinical research trial.
结局指标
主要结局
respiratory degradation event 1
时间窗: during the 4 days period
Capillary saturation \< 94% (regardless of oxygen intake) for at least 2 minutes
respiratory degradation event 2
时间窗: during the 4 days period
an increase in respiratory rate \> 20/minute for at least 2 minutes
次要结局
- New Early Warning Score (NEWS) evaluation(during the 4 days period)
- Assessment of caregiver feelings(during the 4 days period)
- Intensive Care Unit tansfer(during the 4 days period)