COVID-19 Advanced Respiratory Physiology (CARP) Study (CARP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04668313|
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : December 16, 2020
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.
|Condition or disease|
|Respiratory Failure Covid19 Biosensor|
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.
All inpatients in the QEUH with respiratory failure from any cause.
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 :||Observational [Patient Registry]|
|Estimated Enrollment :||150 participants|
|Target Follow-Up Duration:||90 Days|
|Official Title:||COVID-19 Advanced Respiratory Physiology (CARP) Study|
|Actual Study Start Date :||September 29, 2020|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||September 29, 2021|
- Machine-learning model development [ Time Frame: 1 year ]Developing risk-predictions for clinically significant deteriorations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04668313
|Contact: Chris Carlin||01414516088||Christopher.Carlin@ggc.scot.nhs.uk|
|Contact: Jacqueline Anderson||01414516088||Jacqueline.Anderson@ggc.scot.nhs.uk|
|NHS Greater Glasgow and Clyde||Recruiting|
|Glasgow, United Kingdom, G12 0XH|
|Contact: Jacqueline Anderson Jacqueline.Anderson@ggc.scot.nhs.uk|