NCT04927078

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

April 13, 2021

Last Update Submit

June 14, 2021

Conditions

Keywords

Breathing ratePulse rateCOVID 19Patient monitoring

Outcome Measures

Primary Outcomes (1)

  • Breathing rates

    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 Outcomes (2)

  • Pulse rates

    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

    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.

Study Arms (2)

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

Participants without COVID 19 diagnosis

Breathing rates will be measured for the same time duration as the cases.

Other: Observation of breathing pattern

Interventions

Observations will be collected using a remote vision based patient monitoring and management system.

Participants with COVID 19 diagnosisParticipants without COVID 19 diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants admitted to inpatient mental health wards.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coventry and Warwickshire Partnership NHS

Coventry, United Kingdom

Location

MeSH Terms

Conditions

Respiration DisordersCOVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung Diseases

Study Officials

  • Michael Polkey

    The Royal Bromptom Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2021

First Posted

June 15, 2021

Study Start

April 1, 2020

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

June 15, 2021

Record last verified: 2021-06

Locations