DyspneaNCT00878475
Dyspnea and Biomarkers in a Prehospital Setting
An observational study of Dyspnea and Heart Failure, run by Community Healthcare Center dr. Adolf Drolc Maribor (HCM) at 1 site in Slovenia.
Trial summary
In patients presenting with acute dyspnea in a pre-hospital setting, the early and correct diagnosis may present a significant clinical challenge. Physical examination, chest radiography, electrocardiography, and standard biological tests often fail to accurately differentiate heart failure (HF) from pulmonary causes… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dyspnea, Heart Failure, Asthma
- How many people
- 546 participants
- Where
- 1 siteSlovenia
- Study dates
- Jan 2005to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: During the period of the study, 546 consecutive patients with acute dyspnea were treated by emergency teams (emergency physician, register nurse, and medical technician/driver in an ambulance-car or at pre-hospital emergency medical center). After pre-hospital care, all patients were admitted to the University Clinical Center Maribor and followed until discharge. To be eligible for the study, a patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea).
Who may be able to join
- patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea)
Who cannot join
- age <18 years
- history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea:
- pneumonia
- pulmonary embolism
- carcinoma
- pneumothorax
Show all 13Show fewer
- pleural effusion
- intoxications (drugs)
- anaphylactic reactions
- upper airway obstruction
- bronchial stenosis
- gastroesophageal reflux disorder
- according to the history, clinical status, and additional laboratory tests available in pre-hospital setting (D-dimer, troponin, C-reactive protein)
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Health Center Maribor, Center for Emergency Medicine
Maribor, 2000
About this study
Official title: Quantitative Capnometry and Nt-proBNP in Differentiating of Acute Dyspnea in Pre-Hospital Emergency Setting
In patients presenting with acute dyspnea in a pre-hospital setting, the early and correct diagnosis may present a significant clinical challenge. Physical examination, chest radiography, electrocardiography, and standard biological tests often fail to accurately differentiate heart failure (HF) from pulmonary causes of dyspnea. Timely differentiation of HF from other causes of dyspnea may permit the early institution of appropriate medical therapy. Brain natriuretic peptide (BNP) and amino-terminal pro-brain natriuretic peptide (NT-proBNP) have been proposed as early markers of HF and demonstrated to be useful for diagnosing and excluding HF in the emergency department. A combination of BNP or NT-proBNP testing and standard clinical assessment has been suggested to be superior to either tool used in isolation. Some previous studies have also suggested that quantitative capnometry (QC) may be useful in differentiating between cardiac and obstructive causes of respiratory distress. Therefore, the investigators hypothesized that a new combination of NT-proBNP testing, standard clinical assessment, and partial pressure of end-tidal CO2 (PetCO2) would optimize evaluation and differentiation of acute dyspnea in a pre-hospital setting.
The aim of this study was to determine the accuracy of combination of QC, NT-proBNP, and clinical assessment in differentiating acute HF from obstructive pulmonary disease (COPD/asthma) as a cause of acute dyspnea in pre-hospital emergency setting.
- Conditions
- Dyspnea, Heart Failure, Asthma, COPD
- Keywords
- Quantitative Capnometry, N-Terminal Pro-Brain Natriuretic Peptide, Acute Heart Failure, Diagnostic Accuracy
- Medical subject headings
- Dyspnea, Heart Failure, Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group with obstructive causes of dyspnea | Criteria for clinical assessment of severe asthma (diffuse polyphonic bilateral and particular expiratory wheezes, chest tightness, shortness of breath, using accessory muscles of breathing, signs of hyperinflation, atopic condition, personal or family history of asthma, tachypnea, previous asthma and asthma medications, and the value of modified Boston criteria for HF ≤ 5) and criteria for chronic obstructive pulmonary disease (COPD) exacerbation (history of COPD, COPD medications, cough, worsening dyspnea, increased sputum production and volume, increased sputum purulence, rhonchi and rales, modified Boston criteria for HF ≤ 5) | |
| Heart failure group | The investigators protocol for clinical assessment of HF-related acute dyspnea (the prehospital clinical assessment for HF) was designed based on Boston (13) and Framingham criteria for HF (14) (Table 1). The investigators did not use certain criteria from the original protocols, which were not available in the prehospital setting (e.g., chest radiography). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startJan 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community Healthcare Center dr. Adolf Drolc Maribor (HCM)
- Sponsor type
- University, hospital or other
- Investigators
- Štefek Grmec, Prof,MD,PhD, Principal investigator, Health Center, Center for emergency Medicine Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878475
- Sponsor's protocol ID
- grmec62
- Status last verified
- Apr 2009
- First submitted
- 8 Apr 2009
- Last updated
- 9 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Klemen P, Golub M, Grmec S. Combination of quantitative capnometry, N-terminal pro-brain natriuretic peptide, and clinical assessment in differentiating acute heart failure from pulmonary disease as cause of acute dyspnea in pre-hospital emergency setting: study of diagnostic accuracy. Croat Med J. 2009 Apr;50(2):133-42. doi: 10.3325/cmj.2009.50.133.
PubMed 19399946
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Capnometry and Nt-proBNP in Differentiating of Acute Dyspnea in Pre-Hospital Emergency Setting
- ClinicalTrials.gov ID
- NCT00878475
- Acronym / sponsor ID
- grmec62
- Conditions
- Dyspnea, Heart Failure, Asthma, COPD
- Keywords
- Quantitative Capnometry, N-Terminal Pro-Brain Natriuretic Peptide, Acute Heart Failure, Diagnostic Accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Community Healthcare Center dr. Adolf Drolc Maribor (HCM)University, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients presenting with acute dyspnea in a pre-hospital setting, the early and correct diagnosis may present a significant clinical challenge. Physical examination, chest radiography, electrocardiography, and standard biological tests often fail to accurately differentiate heart failure (HF) from pulmonary causes of dyspnea. Timely differentiation of HF from other causes of dyspnea may permit the early institution of appropriate medical therapy. Brain natriuretic peptide (BNP) and amino-terminal pro-brain natriuretic peptide (NT-proBNP) have been proposed as early markers of HF and demonstrated to be useful for diagnosing and excluding HF in the emergency department. A combination of BNP or NT-proBNP testing and standard clinical assessment has been suggested to be superior to either tool used in isolation. Some previous studies have also suggested that quantitative capnometry (QC) may be useful in differentiating between cardiac and obstructive causes of respiratory distress. Therefore, the investigators hypothesized that a new combination of NT-proBNP testing, standard clinical assessment, and partial pressure of end-tidal CO2 (PetCO2) would optimize evaluation and differentiation of acute dyspnea in a pre-hospital setting.
The aim of this study was to determine the accuracy of combination of QC, NT-proBNP, and clinical assessment in differentiating acute HF from obstructive pulmonary disease (COPD/asthma) as a cause of acute dyspnea in pre-hospital emergency setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with obstructive causes of dyspnea | – | –Criteria for clinical assessment of severe asthma (diffuse polyphonic bilateral and particular expiratory wheezes, chest tightness, shortness of breath, using accessory muscles of breathing, signs of hyperinflation, atopic condition, personal or family history of asthma, tachypnea, previous asthma and asthma medications, and the value of modified Boston criteria for HF ≤ 5) and criteria for chronic obstructive pulmonary disease (COPD) exacerbation (history of COPD, COPD medications, cough, worsening dyspnea, increased sputum production and volume, increased sputum purulence, rhonchi and rales, modified Boston criteria for HF ≤ 5) |
| Heart failure group | – | –The investigators protocol for clinical assessment of HF-related acute dyspnea (the prehospital clinical assessment for HF) was designed based on Boston (13) and Framingham criteria for HF (14) (Table 1). The investigators did not use certain criteria from the original protocols, which were not available in the prehospital setting (e.g., chest radiography). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- During the period of the study, 546 consecutive patients with acute dyspnea were treated by emergency teams (emergency physician, register nurse, and medical technician/driver in an ambulance-car or at pre-hospital emergency medical center). After pre-hospital care, all patients were admitted to the University Clinical Center Maribor and followed until discharge. To be eligible for the study, a patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea).
Key inclusion criteria (1 listed)
- patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea)
Key exclusion criteria (13 listed)
- age <18 years
- history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea:
- according to the history, clinical status, and additional laboratory tests available in pre-hospital setting (D-dimer, troponin, C-reactive protein)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2009.
- Derived from this study: PubMed 19399946Klemen P, Golub M, Grmec S. Combination of quantitative capnometry, N-terminal pro-brain natriuretic peptide, and clinical assessment in differentiating acute heart failure from pulmonary disease as cause of acute dyspnea in pre-hospital emergency setting: study of diagnostic accuracy. Croat Med J. 2009 Apr;50(2):133-42. doi: 10.3325/cmj.2009.50.133.
Related trials for Dyspnea
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Štefek Grmec, Prof,MD,PhD principal investigator
Health Center, Center for emergency Medicine Maribor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea and Heart Failure, run by Community Healthcare Center dr. Adolf Drolc Maribor (HCM) at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2009.