Respiratory Tele Monitoring COVID 19 (TMR COVID-19)

Interest of Respiratory Tele Monitoring in COVID-19 Pneumonia

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Device: usual monitoring; Device: Radius PPG Tetherless Pulse Oximetry (Masimo)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre MICHELET; Phone Number: +33 04 13 42 97 05; Email: pierre.michelet@ap-hm.fr
• Study Contact Backup: Name: Claire MORANDO; Phone Number: +33 0491382183; Email: claire.morando@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13005
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: Pierre MICHELET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control Respiratory Monitoring Group	Device: usual monitoring; usual nurse respiratory monitoring
EXPERIMENTAL: Experimental Respiratory Monitoring Group	Device: Radius PPG Tetherless Pulse Oximetry (Masimo); continuous monitoring by a portable, wireless and stand-alone device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 22, 2020
• Primary Completion (ANTICIPATED): May 15, 2021
• Study Completion (ANTICIPATED): November 15, 2021

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (ACTUAL): March 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-35; 2020-A01627-32 (REGISTRY: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No