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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
Sponsor:
Collaborators:
Altair Medical
Storm ID
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Study Description
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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.


Condition or disease
Respiratory Failure Covid19 Biosensor

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Machine-learning model development [ Time Frame: 1 year ]
    Developing risk-predictions for clinically significant deteriorations


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Potential participants with respiratory failure will be identified by the clinical teams in the emergency departments, admissions units, respiratory wards or high dependency units of the study sites. Patient information sheets would be provided to potential participants. Study team will liase with clinical staff to identify potential participants and maintain a screening and recruitment log. Based on this information, a member of the team delivering the trial with appropriate knowledge will assess eligibility against inclusion and exclusion criteria. No additional tests are required to determine eligibility.
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
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Contact: Chris Carlin 01414516088 Christopher.Carlin@ggc.scot.nhs.uk
Contact: Jacqueline Anderson 01414516088 Jacqueline.Anderson@ggc.scot.nhs.uk

Locations
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United Kingdom
NHS Greater Glasgow and Clyde Recruiting
Glasgow, United Kingdom, G12 0XH
Contact: Jacqueline Anderson       Jacqueline.Anderson@ggc.scot.nhs.uk   
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Altair Medical
Storm ID
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT04668313    
Other Study ID Numbers: INGN20RM136
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Insufficiency
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders