- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04668313
COVID-19 Advanced Respiratory Physiology (CARP) Study (CARP)
The anticipated second wave of COVID-19 cases will present healthcare system challenges, including requirement to monitor large numbers of patients for deteriorating respiratory failure. Rising respiratory rate can identify deterioration requiring escalation of care. However constant monitoring of respiratory rate can be challenging outwith critical care units due to feasibility and inaccuracy of intermittent measurements.
Wearable biosensors which allows for remote patient monitoring of RR is therefore attractive, particularly when combined in a dashboard with clinical summary data. This would establish source data and infrastructure for the training and validation of machine-learning models, with decision support risk-predictions prioritising alerts and clinician reviews.
Study Overview
Status
Conditions
Detailed Description
Altair medical has developed a pre-commercial investigational wearable (chest-worn) biosensor which can measure continuous respiratory rate and respiratory events. This sensor has been verified to have good correlation with reference impedance plethysmography data.
Inclusion criteria:
All inpatients in the QEUH with respiratory failure from any cause.
Exclusion criteria:
Lack of capacity to consent
Physiology data will be correlated with event time-course data including oxygen and breathing support requirements, deterioration, hospital discharge and status at 28 days and 90 days post discharge.
A small subset of patients will have further investigations - parasternal EMG; thoracic electrical impedance tomography; forced oscillometry and post discharge Altair and Fitbit data.
Study analysis will include machine learning model development with the objective of developing risk-predictions for clinically significant deteriorations.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chris Carlin
- Phone Number: 01414516088
- Email: Christopher.Carlin@ggc.scot.nhs.uk
Study Contact Backup
- Name: Jacqueline Anderson
- Phone Number: 01414516088
- Email: Jacqueline.Anderson@ggc.scot.nhs.uk
Study Locations
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Glasgow, United Kingdom, G12 0XH
- Recruiting
- NHS Greater Glasgow and Clyde
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Contact:
- Jacqueline Anderson
- Email: Jacqueline.Anderson@ggc.scot.nhs.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Inclusion criteria
- Adult patients with respiratory failure of any cause requiring hospital admission, oxygen therapy and routine NEWS-2 physiology observations.
- CARP detailed sub-study Adult patients with respiratory failure who are suitable for opportunistically acquired serial detailed physiology measurements taken alongside routine clinical care by study team.
- CARP follow-up remote-monitoring sub-study Adult patients with respiratory failure who have provided informed consent and have a smartphone to connect to Fitbit and Lenus accounts for postdischarge wearable device data capture.
Exclusion Criteria:
- Exclusion criteria • Lack of capacity or inability to comprehend informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Machine-learning model development
Time Frame: 1 year
|
Developing risk-predictions for clinically significant deteriorations
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INGN20RM136
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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