Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers

NCT05304494 | Withdrawn

• 1 other identifier: Sentinel - 001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breathlessness; COPD; Asthma; Asthma Chronic; Wheezing; Dyspnea; Shortness of Breath

Keywords

Breathlessness; COPD; Asthma; Asthma Chronic; Wheezing; Dyspnea; Shortness of Breath

Outcome Measures

Primary Outcomes (1)

• Physician assessed severity 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

  1 day (One-time assessment during a participant reported episode of breathlessness)

Study Arms (3)

Severe Breathlessness

Breathlessness requiring admission or supplementary oxygen

Other: Biomarker tests for participant profiling

Moderate Breathlessness

Breathlessness requiring medical intervention \< 24 hours without meeting the criteria for severe breathlessness

Other: Biomarker tests for participant profiling

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

Interventions

Biomarker tests for participant profiling OTHER

Combination of digital and physical tests to objectify measures relevant for breathlessness

Mild Breathlessness; Moderate Breathlessness; Severe Breathlessness

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanome: lead

Related Publications (5)

• 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.

  PMID: 27603500 BACKGROUND

• 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.

  PMID: 32539537 BACKGROUND

• 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.

  PMID: 23971625 BACKGROUND

• 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.

  PMID: 27354781 BACKGROUND

• 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.

  PMID: 12513067 BACKGROUND

Related Links

• 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

MeSH Terms

Conditions

Dyspnea; Pulmonary Disease, Chronic Obstructive; Asthma; Respiratory Sounds

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 31, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 13, 2022

Record last verified: 2022-03