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Dyspnea | Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers

Dyspnea research study

What is the primary objective of this study?

Breathlessness is a dangerous symptom. Preliminary data from national and regional Danish databases show, that patients with shortness of breath in the ambulance have a very high mortality. Breathlessness can be caused by many different conditions - but heart diseases and lung diseases are dominant. The mortality is especially high in patients with breathlessness caused by heart disease. Distinguishing these different causes of breathlessness is a classical, often difficult, discipline in medicine. Visitation and guidance of treatment in patients with breathlessness in the prehospital setting relies on medical history and physical examination and as a consequence prehospital treatment for breathlessness is often non-specific. The use of heart-failure specific biomarkers may improve prehospital visitation and treatment of patients with breathlessness. We hypothesize, that 1. Supplementing the routine examination by prehospital anesthesiologist with measurement of a biomarker for heart failure increases the proportion of patients with severe shortness of breath caused by heart disease triaged directly to department of cardiology 2. This strategy does not increase the proportion of patients with severe shortness of breath caused by non-heart disease triaged directly to department of cardiology

Who is eligible to participate?

Inclusion Criteria: All patients requiring dispatch of emergency physician because of severe dyspnea. Severe dyspnea is defined by dyspnea plus at least ONE of the following - Respiration frequency > 20 or < 8 - Saturation < 96 without supplementary oxygen - Heart rate > 100 or < 50 - Systolic blood pressure < 100 or > 200 - Difficulty talking - Central or peripheral cyanosis - Use of accessory muscles of respiration - Glasgow coma scale score < 15 AND because of the physical condition, the patient is not able to give informed consent Exclusion Criteria Age < 18

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dyspnea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Supplementary NT-proBNP measurementIn patients randomized to the strategy with supplementary measurement of NT-proBNP, a blood sample will be drawn from the peripheral venous catheter that is routinely inserted and analyzed immediately using a COBAS H232 and Roche Diagnostics NT-proBNP assay.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Business as usualTriage and treatment based on routine clinical assessment as usual

Supplementary NT-proBNP measurementTriage and treatment based on routine clinical assessment supplemented with measurement of NT-proBNP

Study Status

Completed

Start Date: February 2014

Completed Date: May 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Proportion of patients with dyspnea caused by heart disease initially triaged to department of cardiology

Secondary Outcome: Proportion of patients with dyspnea of other etiologies initially triaged to department of cardiology

Study sponsors, principal investigator, and references

Principal Investigator: Morten Thingemann B√łtker, MD

Lead Sponsor: University of Aarhus

Collaborator: Central Denmark Region

More information:https://clinicaltrials.gov/show/NCT02050282

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