Dyspnea
Conditions
Keywords
Dyspnea, Prehospital, Biomarker, Heart failure, Triage, Randomized, controlled study
Brief summary
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
Detailed description
Measurement of the biomarker for heart failure N-terminal pro-Brain Natriuretic Peptide (NT-proBNP): In 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. This will be analyzed point-of-care in the ambulance. Interpretation of NT-proBNP: Cut-off values based on bootstrap-validated optimal cut-points for heart failure on will be used. Confirmatory ('rule in') cut point \< 50 years: 450 pg/mL 50-75 years: 900 pg/mL \> 75 years: 1800 pg/mL Exclusionary ('rule out') cut point All patients: 300 pg/mL The emergency physicians will be thoroughly informed about these cut-points, but told not to triage to department of cardiology or other department strictly according to NT-proBNP, but according to clinical assessment AND NT-proBNP.
Interventions
OTHERSupplementary NT-proBNP measurement
In 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.
Sponsors
Central Denmark Region
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with dyspnea caused by heart disease initially triaged to department of cardiology | Within 1 day from randomization | An endpoint committee determines final diagnoses as dyspnea caused by heart disease, dyspnea caused by lung disease and dyspnea caused by other diseases based on clinical and paraclinical data excluding prehospital NT-pro-BNP value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with dyspnea caused by heart disease that receives pulmonary medication | Within 1 day | beta2-agonist inhalations, combined ipratropium/b2-agonist inhalations, intravenous b2-agonists, intravenous corticosteroids |
| Length of hospital stay | Up to three months from randomization | Time from hospital admission related to the inclusion event to discharge from hospital |
| Intensive care unit admission rate | Up to three months from randomization | Within the time from hospital admission related to the inclusion event to discharge from hospital related to inclusion event |
| All-cause re-admission | Within 3 months of randomization | — |
| Proportion of patients with dyspnea of other etiologies initially triaged to department of cardiology | Within 1 day from randomization | An endpoint committee determines final diagnoses as dyspnea of cardiac origin and dyspnea of non-cardiac origin based on clinical and paraclinical data excluding prehospital NT-pro-BNP value |
| All-cause mortality | Within 30 days of randomization | — |
| Proportion of patients with dyspnea caused by lung disease, that receives traditional heart failure medication | Within 1 day | Loop diuretics, nitrates, opiates |
| Proportion of patients with correct diagnosis of congestive heart failure in the prehospital setting | Within 1 day of randomization | An endpoint committee determines final diagnoses based on clinical and paraclinical data excluding prehospital NT-pro-BNP value |
| Proportion of patients where congestive heart failure is correctly disproved in the prehospital setting | Within 1 day of randomization | An endpoint committee determines final diagnoses based on clinical and paraclinical data excluding prehospital NT-pro-BNP value |
| Proportion of patients not admitted to hospital | Within 24 hours | Proportion of patients not admitted to hospital in relation to the inclusion event |
Countries
Denmark
Outcome results
None listed