Respiratory Tele Monitoring COVID 19 (TMR COVID-19)

Summary

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.

Conditions

• Covid19

Interventions

DEVICE

Radius PPG Tetherless Pulse Oximetry (Masimo)

continuous monitoring by a portable, wireless and stand-alone device

DEVICE

usual monitoring

usual nurse respiratory monitoring

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille

  lead OTHER

Principal Investigators

• GARRIDO-PRADALIE Emilie · Assistance Publique Hôpitaux de Marseille

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-22

Primary Completion

2021-05-26

Completion

2021-05-26

Countries

• France

Study Locations