Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers
Study Details
Study Description
Brief Summary
The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Severe Breathlessness Breathlessness requiring admission or supplementary oxygen |
Other: Biomarker tests for participant profiling
Combination of digital and physical tests to objectify measures relevant for breathlessness
|
| Moderate Breathlessness Breathlessness requiring medical intervention < 24 hours without meeting the criteria for severe breathlessness |
Other: Biomarker tests for participant profiling
Combination of digital and physical tests to objectify measures relevant for breathlessness
|
| Mild Breathlessness Breathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan |
Other: Biomarker tests for participant profiling
Combination of digital and physical tests to objectify measures relevant for breathlessness
|
Outcome Measures
Primary Outcome Measures
- Physician assessed severity of breathlessness [1 day (One-time assessment during a participant reported episode of breathlessness)]
Breathlessness requiring admission or supplementary oxygen, breathlessness requiring intervention < 24 hours, Breathlessness requiring medical intervention within 24 hours without meeting the criteria for severe breathlessness, Breathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged 18-90 years.
-
Has experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional. Self-reported breathlessness using any of the following words to describe symptoms will qualify as a presentation of breathlessness regardless of aetiology or severity of symptoms: shortness of breath, tight chest, trouble breathing, breathlessness, dyspnoeic, breathless, asthmatic, suffocating, wheezing, fighting for breath or any equivalent word. Breathlessness does not have to be the primary presenting symptom.
-
Deemed clinically sufficiently stable to participate according to health care practitioner.
Exclusion Criteria:
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Inability to understand written local language at a year 5 level.
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Not being confident in use of digital technology (smartphone and/or tablet). This will become evident through an inability to use the system.
-
Inability to enter required study sample data due to diminished consciousness and/or physical or mental capacity regardless of whether this is associated with the breathlessness event.
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Received an investigational medical product in the context of a Clinical Trial during the 28 days prior to first probe administration.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sanome
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Health Research Authority. Is my study research?
- MHRA, Health and care research Wales, NHS Scotland, Health and Social Care & NHS Health Research Authority. Joint statement on seeking consent by electronic methods
Publications
- Barnes N, Calverley PM, Kaplan A, Rabe KF. Chronic obstructive pulmonary disease and exacerbations: patient insights from the global Hidden Depths of COPD survey. BMC Pulm Med. 2013 Aug 23;13:54. doi: 10.1186/1471-2466-13-54.
- Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Moher D, Rennie D, de Vet HC, Lijmer JG; Standards for Reporting of Diagnostic Accuracy. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med. 2003 Jan 7;138(1):W1-12.
- Coutinho AD, Lokhandwala T, Boggs RL, Dalal AA, Landsman-Blumberg PB, Priest J, Stempel DA. Prompt initiation of maintenance treatment following a COPD exacerbation: outcomes in a large insured population. Int J Chron Obstruct Pulmon Dis. 2016 Jun 8;11:1223-31. doi: 10.2147/COPD.S102570. eCollection 2016.
- Smith AK, Currow DC, Abernethy AP, Johnson MJ, Miao Y, Boscardin WJ, Ritchie CS. Prevalence and Outcomes of Breathlessness in Older Adults: A National Population Study. J Am Geriatr Soc. 2016 Oct;64(10):2035-2041. doi: 10.1111/jgs.14313. Epub 2016 Sep 7.
- Tobin MJ, Laghi F, Jubran A. Why COVID-19 Silent Hypoxemia Is Baffling to Physicians. Am J Respir Crit Care Med. 2020 Aug 1;202(3):356-360. doi: 10.1164/rccm.202006-2157CP.
- Sentinel - 001