Respiratory DiseaseNCT04927078
Analysis of Vital Signs in Patients With COVID-19
An observational study of Respiratory Disease, run by Oxehealth Limited at 1 site in United Kingdom.
Trial summary
This project will use data obtained from a proprietary vision-based patient monitoring and management system (OxeVision) for measuring heart rate and respiratory rate which is in clinical use at the Coventry and Warwickshire Partnership NHS Trust. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Observation of breathing pattern
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2020to 31 Oct 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants admitted to inpatient mental health wards.
Who may be able to join
- Patients age 18 and above. Patients on wards with a medical diagnosis of COVID 19 who are in rooms with the Vision based patient monitoring and management system.
Who cannot join
- Children will be excluded. No data will be excluded unless specifically requested by the treating clinician.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Coventry and Warwickshire Partnership NHS
Coventry
About this study
This project will use data obtained from a proprietary vision-based patient monitoring and management system (OxeVision) for measuring heart rate and respiratory rate which is in clinical use at the Coventry and Warwickshire Partnership NHS Trust.
Read the detailed description
The investigators will analyse data from patients with known COVID 19 infection both during, and where possible before clinical COVID 19 infection and controls to determine whether changes can be detected in these parameters that precede overt clinical deterioration. The role of remote vision-based patient monitoring and management in supporting the care of patients with COVID-19 will be assessed through staff interviews.
- Conditions
- Respiratory Disease
- Being tested
- Observation of breathing pattern
- Keywords
- Breathing rate, Pulse rate, COVID 19, Patient monitoring
- Medical subject headings
- Respiration Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of breathing patternOther
Observations will be collected using a remote vision based patient monitoring and management system.
| Study group | Role | What they receive |
|---|---|---|
| Participants with COVID 19 diagnosis | We will measure the breathing rate (BR) before and after the clinical diagnosis of COVID 19. Receives: Other: Observation of breathing pattern | |
| Participants without COVID 19 diagnosis | Breathing rates will be measured for the same time duration as the cases. Receives: Other: Observation of breathing pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing rates
Breathing rates collected via remote monitoring of participants using the Vision Based Patient Monitoring and Management System.
Measured: Data will be collected throughout study completion, an average of 7 months, to obtain breathing rate before and after the diagnosis of COVID 19.
Secondary outcomes (2)
Pulse rates
Pulse rate collected via remote monitoring of participants using the Vision Based Patient Monitoring and Management System.
Measured: Data will be collected throughout study completion, an average of 7 months, to obtain pulse rate before and after the diagnosis of COVID 19.
BR and PR
Similar data to be collected from control subjects
Measured: Data will be collected throughout study completion, an average of 7 months, to obtain breathing and pulse rate before and after the diagnosis of COVID 19.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start1 Apr 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxehealth Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Michael Polkey, Principal investigator, The Royal Bromptom Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927078
- Sponsor's protocol ID
- 287454
- Status last verified
- Jun 2021
- First submitted
- 13 Apr 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Vital Signs in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04927078
- Acronym / sponsor ID
- 287454
- Conditions
- Respiratory Disease
- Keywords
- Breathing rate, Pulse rate, COVID 19, Patient monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oxehealth LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 15 Jun 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.
This project will use data obtained from a proprietary vision-based patient monitoring and management system (OxeVision) for measuring heart rate and respiratory rate which is in clinical use at the Coventry and Warwickshire Partnership NHS Trust.
Detailed description
The investigators will analyse data from patients with known COVID 19 infection both during, and where possible before clinical COVID 19 infection and controls to determine whether changes can be detected in these parameters that precede overt clinical deterioration. The role of remote vision-based patient monitoring and management in supporting the care of patients with COVID-19 will be assessed through staff interviews.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with COVID 19 diagnosis | – | Other: Observation of breathing patternWe will measure the breathing rate (BR) before and after the clinical diagnosis of COVID 19. |
| Participants without COVID 19 diagnosis | – | Other: Observation of breathing patternBreathing rates will be measured for the same time duration as the cases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants admitted to inpatient mental health wards.
Key inclusion criteria (1 listed)
- Patients age 18 and above. Patients on wards with a medical diagnosis of COVID 19 who are in rooms with the Vision based patient monitoring and management system.
Key exclusion criteria (1 listed)
- Children will be excluded. No data will be excluded unless specifically requested by the treating clinician.
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 |
|---|---|---|
| Observation of breathing patternObservations will be collected using a remote vision based patient monitoring and management system. | Other | Participants with COVID 19 diagnosis, Participants without COVID 19 diagnosis |
Primary outcome
Breathing rates
Time frame: Data will be collected throughout study completion, an average of 7 months, to obtain breathing rate before and after the diagnosis of COVID 19.
Breathing rates collected via remote monitoring of participants using the Vision Based Patient Monitoring and Management System.
2 secondary outcomes
Pulse rates
Time frame: Data will be collected throughout study completion, an average of 7 months, to obtain pulse rate before and after the diagnosis of COVID 19.
BR and PR
Time frame: Data will be collected throughout study completion, an average of 7 months, to obtain breathing and pulse rate before and after the diagnosis of COVID 19.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Michael Polkey principal investigator
The Royal Bromptom Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease, run by Oxehealth Limited at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jun 2021. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Breathing rates (time frame: Data will be collected throughout study completion, an average of 7 months, to obtain breathing rate before and after the diagnosis of COVID 19.). 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 15 Jun 2021.