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COVID-19 Advanced Respiratory Physiology (CARP) Study

COVID-19 Advanced Respiratory Physiology (CARP) Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04668313
Acronym
CARP
Enrollment
150
Registered
2020-12-16
Start date
2020-09-29
Completion date
2021-09-29
Last updated
2020-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biosensor, Covid19, Respiratory Failure

Brief summary

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.

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.

Interventions

None listed

Sponsors

Altair Medical
CollaboratorUNKNOWN
Storm ID
CollaboratorUNKNOWN
NHS Greater Glasgow and Clyde
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

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

*

Design outcomes

Primary

MeasureTime frameDescription
Machine-learning model development1 yearDeveloping risk-predictions for clinically significant deteriorations

Countries

United Kingdom

Contacts

Primary ContactChris Carlin
Christopher.Carlin@ggc.scot.nhs.uk01414516088
Backup ContactJacqueline Anderson
Jacqueline.Anderson@ggc.scot.nhs.uk01414516088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026