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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01627-32 | Registry Identifier | IDRCB |
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the number of participants included is expected before the planned end date
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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:
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:
The modification of the therapeutic strategy is defined by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Respiratory Monitoring Group | Active Comparator |
| |
| Experimental Respiratory Monitoring Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radius PPG Tetherless Pulse Oximetry (Masimo) | Device | continuous monitoring by a portable, wireless and stand-alone device |
|
| Measure | Description | Time Frame |
|---|---|---|
| respiratory degradation event 1 | Capillary saturation < 94% (regardless of oxygen intake) for at least 2 minutes | during the 4 days period |
| respiratory degradation event 2 | an increase in respiratory rate > 20/minute for at least 2 minutes | during the 4 days period |
| Measure | Description | Time Frame |
|---|---|---|
| New Early Warning Score (NEWS) evaluation | post hoc comparison of the respiratory monitoring using the experimental device with the NEWS on the repiratory event occurence | during the 4 days period |
| Assessment of caregiver feelings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GARRIDO-PRADALIE Emilie | Assistance Publique Hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Marseille | Marseille | 13005 | France |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| usual monitoring | Device | usual nurse respiratory monitoring |
|
post hoc analysis of the team in regard to the monitoring strategy used based on a self-assessment questionnaire
| during the 4 days period |
| Intensive Care Unit tansfer | post hoc analysis of the frequency of ICU transfer | during the 4 days period |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |