Respiratory Tele Monitoring COVID 19 (TMR COVID-19)

NCT ID: NCT04821973

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2021-05-26

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Respiratory Monitoring Group

Group Type: ACTIVE_COMPARATOR

usual monitoring

Intervention Type: DEVICE

usual nurse respiratory monitoring

Experimental Respiratory Monitoring Group

Group Type: EXPERIMENTAL

Radius PPG Tetherless Pulse Oximetry (Masimo)

Intervention Type: DEVICE

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

Interventions

Radius PPG Tetherless Pulse Oximetry (Masimo)

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

Intervention Type: DEVICE

usual monitoring

usual nurse respiratory monitoring

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GARRIDO-PRADALIE Emilie

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2020-A01627-32

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-35

Identifier Type: -

Identifier Source: org_study_id