Clinical trial NCT05304494: Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers
Official title: Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breathlessness
COPD
Asthma
Asthma Chronic
Wheezing
Dyspnea
Shortness of Breath
Keywords: Breathlessness
COPD
Asthma
Asthma Chronic
Wheezing
Dyspnea
Shortness of Breath
Lead sponsor: Sanome
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants having experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional.

Brief summary: The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.


Eligibility 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:

* Inability to understand written local language at a year 5 level.
* 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.
* Received an investigational medical product in the context of a Clinical Trial during the 28 days prior to first probe administration.

Primary outcomes:
measure: Physician assessed severity of breathlessness
timeFrame: 1 day (One-time assessment during a participant reported episode of breathlessness)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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. doi: 10.7326/0003-4819-138-1-200301070-00012-w1.