Respiratory Tele Monitoring COVID 19 (TMR COVID-19)
Primary Purpose
Covid19
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radius PPG Tetherless Pulse Oximetry (Masimo)
usual monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Covid19
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.
Sites / Locations
- Assistance Publique Hôpitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Respiratory Monitoring Group
Experimental Respiratory Monitoring Group
Arm Description
Outcomes
Primary Outcome Measures
respiratory degradation event 1
Capillary saturation < 94% (regardless of oxygen intake) for at least 2 minutes
respiratory degradation event 2
an increase in respiratory rate > 20/minute for at least 2 minutes
Secondary Outcome Measures
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
Assessment of caregiver feelings
post hoc analysis of the team in regard to the monitoring strategy used based on a self-assessment questionnaire
Intensive Care Unit tansfer
post hoc analysis of the frequency of ICU transfer
Full Information
NCT ID
NCT04821973
First Posted
March 25, 2021
Last Updated
March 29, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT04821973
Brief Title
Respiratory Tele Monitoring COVID 19 (TMR COVID-19)
Official Title
Interest of Respiratory Tele Monitoring in COVID-19 Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
May 15, 2021 (Anticipated)
Study Completion Date
November 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Respiratory Monitoring Group
Arm Type
Active Comparator
Arm Title
Experimental Respiratory Monitoring Group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Radius PPG Tetherless Pulse Oximetry (Masimo)
Intervention Description
continuous monitoring by a portable, wireless and stand-alone device
Intervention Type
Device
Intervention Name(s)
usual monitoring
Intervention Description
usual nurse respiratory monitoring
Primary Outcome Measure Information:
Title
respiratory degradation event 1
Description
Capillary saturation < 94% (regardless of oxygen intake) for at least 2 minutes
Time Frame
during the 4 days period
Title
respiratory degradation event 2
Description
an increase in respiratory rate > 20/minute for at least 2 minutes
Time Frame
during the 4 days period
Secondary Outcome Measure Information:
Title
New Early Warning Score (NEWS) evaluation
Description
post hoc comparison of the respiratory monitoring using the experimental device with the NEWS on the repiratory event occurence
Time Frame
during the 4 days period
Title
Assessment of caregiver feelings
Description
post hoc analysis of the team in regard to the monitoring strategy used based on a self-assessment questionnaire
Time Frame
during the 4 days period
Title
Intensive Care Unit tansfer
Description
post hoc analysis of the frequency of ICU transfer
Time Frame
during the 4 days period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre MICHELET
Phone
04 13 42 97 05
Ext
+33
Email
pierre.michelet@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Claire MORANDO
Phone
0491382183
Ext
+33
Email
claire.morando@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GARRIDO-PRADALIE Emilie
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre MICHELET
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Respiratory Tele Monitoring COVID 19 (TMR COVID-19)
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