Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers
- Conditions
- Dyspnea
- Interventions
- Other: Supplementary NT-proBNP measurement
- Registration Number
- NCT02050282
- Lead Sponsor
- University of Aarhus
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 712
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supplementary NT-proBNP measurement Supplementary NT-proBNP measurement Triage and treatment based on routine clinical assessment supplemented with measurement of NT-proBNP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method All-cause mortality Within 30 days of randomization 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
Proportion of patients not admitted to hospital Within 24 hours Proportion of patients not admitted to hospital in relation to the inclusion event
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 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
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 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
Trial Locations
- Locations (9)
Critical Care Team Holstebro
🇩🇰Holstebro, Central Denmark Region, Denmark
Critical Care Team Horsens, Prehospital Emergency Medical Services
🇩🇰Horsens, Central Denmark Region, Denmark
Critical Care Team Aarhus, Prehospital Emergency Medical Services
🇩🇰Aarhus, Central Denmark Region, Denmark
Critical Care Team Grenaa, Prehospital Emergency Medical Services
🇩🇰Grenaa, Central Denmark Region, Denmark
Critical Care Team, Lemvig, Prehospital Emergency Medical Services
🇩🇰Lemvig, Central Denmark Region, Denmark
Critical Care Team Herning, Prehospital Emergency Medical Services
🇩🇰Herning, Central Denmark Region, Denmark
Critical Care Team Randers, Prehospital Emergency Medical Services
🇩🇰Randers, Central Denmark Region, Denmark
Critical Care Team Silkeborg, Prehospital Emergency Medical Services
🇩🇰Silkeborg, Central Denmark Region, Denmark
Critical Care Team, Viborg, Prehospital Emergency Medical Services
🇩🇰Viborg, Central Denmark Region, Denmark