Covid19NCT04821973
Respiratory Tele Monitoring COVID 19 (TMR COVID-19)
A study testing Radius PPG Tetherless Pulse Oximetry (Masimo) and usual monitoring in people with Covid19, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Radius PPG Tetherless Pulse Oximetry (Masimo) and usual monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2020to 26 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Radius PPG Tetherless Pulse Oximetry (Masimo), usual monitoring
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radius PPG Tetherless Pulse Oximetry (Masimo)Device
continuous monitoring by a portable, wireless and stand-alone device
usual monitoringDevice
usual nurse respiratory monitoring
| Study group | Role | What they receive |
|---|---|---|
| Control Respiratory Monitoring Group | Active comparator | Not described Receives: Device: usual monitoring |
| Experimental Respiratory Monitoring Group | Experimental | Not described Receives: Device: Radius PPG Tetherless Pulse Oximetry (Masimo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory degradation event 1
Capillary saturation < 94% (regardless of oxygen intake) for at least 2 minutes
Measured: during the 4 days period
respiratory degradation event 2
an increase in respiratory rate > 20/minute for at least 2 minutes
Measured: during the 4 days period
Secondary outcomes (3)
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
Measured: 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
Measured: during the 4 days period
Intensive Care Unit tansfer
post hoc analysis of the frequency of ICU transfer
Measured: during the 4 days period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start22 Sep 2020
- Primary completion26 May 2021
- Study completion26 May 2021
Why it stopped: the number of participants included is expected before the planned end date
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GARRIDO-PRADALIE Emilie, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821973
- Sponsor's protocol ID
- 2020-35
- Other IDs
- 2020-A01627-32
- Status last verified
- Jun 2024
- First submitted
- 25 Mar 2021
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Respiratory Tele Monitoring in COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04821973
- Acronym / sponsor ID
- 2020-35
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the number of participants included is expected before the planned end date
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Respiratory Monitoring Group | Active comparator | Device: usual monitoring |
| Experimental Respiratory Monitoring Group | Experimental | Device: Radius PPG Tetherless Pulse Oximetry (Masimo) |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radius PPG Tetherless Pulse Oximetry (Masimo)continuous monitoring by a portable, wireless and stand-alone device | Device | Experimental Respiratory Monitoring Group |
| usual monitoringusual nurse respiratory monitoring | Device | Control Respiratory Monitoring Group |
Primary outcome
respiratory degradation event 1
Time frame: during the 4 days period
Capillary saturation < 94% (regardless of oxygen intake) for at least 2 minutes
respiratory degradation event 2
Time frame: during the 4 days period
an increase in respiratory rate > 20/minute for at least 2 minutes
3 secondary outcomes
New Early Warning Score (NEWS) evaluation
Time frame: during the 4 days period
Assessment of caregiver feelings
Time frame: during the 4 days period
Intensive Care Unit tansfer
Time frame: during the 4 days period
Results and safety
The study was stopped early (reason given: the number of participants included is expected before the planned end date). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GARRIDO-PRADALIE Emilie study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radius PPG Tetherless Pulse Oximetry (Masimo) and usual monitoring in people with Covid19, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the number of participants included is expected before the planned end date). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory degradation event 1 (time frame: during the 4 days period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.