Analysis of Vital Signs in Patients With COVID-19

June 14, 2021 updated by: Oxehealth Limited
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Coventry, United Kingdom
        • Coventry and Warwickshire Partnership NHS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult participants admitted to inpatient mental health wards.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

Children will be excluded. No data will be excluded unless specifically requested by the treating clinician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with COVID 19 diagnosis
We will measure the breathing rate (BR) before and after the clinical diagnosis of COVID 19.
Other: Observation of breathing pattern
Observations will be collected using a remote vision based patient monitoring and management system.
Participants without COVID 19 diagnosis
Breathing rates will be measured for the same time duration as the cases.
Other: Observation of breathing pattern
Observations will be collected using a remote vision based patient monitoring and management system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pulse rate collected via remote monitoring of participants using the Vision Based Patient Monitoring and Management System.
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.
Similar data to be collected from control subjects
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxehealth Limited

Collaborators

Royal Brompton & Harefield NHS Foundation Trust

Investigators

  • Principal Investigator: Michael Polkey, The Royal Bromptom Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Actual)

June 15, 2021

Last Update Submitted That Met QC Criteria

June 14, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 287454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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