Respiratory Tele Monitoring COVID 19 (TMR COVID-19)

NCT04821973 | Terminated DMC

• 2 other identifiers: 2020-352020-A01627-32
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

Control Respiratory Monitoring Group

ACTIVE COMPARATOR

Device: usual monitoring

Experimental Respiratory Monitoring Group

EXPERIMENTAL

Device: Radius PPG Tetherless Pulse Oximetry (Masimo)

Interventions

Radius PPG Tetherless Pulse Oximetry (Masimo) DEVICE

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

Experimental Respiratory Monitoring Group

usual monitoring DEVICE

usual nurse respiratory monitoring

Control Respiratory Monitoring Group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• GARRIDO-PRADALIE Emilie

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 30, 2021
• Study Start: September 22, 2020
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)