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Compares treatment options for Pulmonary Edema Cardiac Cause
Official title HF vs NIV in Acute Cardiogenic Pulmonary Edema
ClinicalTrials.gov ID: NCT05989139
What this study is testing
- What it's testing
- The study's primary aim is to compare the effects of two different ventilation modalities, non-invasive positive-pressure ventilation (NPPV) and high-flow nasal cannulae (HFNC), in the acute cardiogenic pulmonary edema (ACPE) setting, in terms of echocardiographic parameters of RV systolic and RV strain. to determine the differences of the two interventions on other hemodynamic parameters echocardiographically assessed.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 y.o.;
- Clinical diagnosis of ACPE in the setting of either AMI, acute myocarditis, acute/chronic severe mitral/aortic valve regurgitation, severe...
- Hypertensive crisis with systolic blood pressure \>200 mmHg;
- Other congenital or acquired structural heart disease causing post capillary pulmonary hypertension or combination of the previous.
- Written informed consent.
You likely can't join if
- Age \<18 y.o.;
- Hypercapnia with respiratory acidosis (PaCO2 \> 45 mmHg with pH \< 7.35);
- History of fever in the previous 4 days;
- White blood cell count \> 12.000;
- Increased procalcitonin serum levels;
- Consolidative areas at chest radiograph;
See the full eligibility criteria
- Age ≥ 18 y.o.;
- Clinical diagnosis of ACPE in the setting of either AMI, acute myocarditis, acute/chronic severe mitral/aortic valve regurgitation, severe mitral/aortic stenosis, acute/chronic HF with rLVEF diagnosed according to...
- Hypertensive crisis with systolic blood pressure \>200 mmHg;
- Other congenital or acquired structural heart disease causing post capillary pulmonary hypertension or combination of the previous.
- Written informed consent.
- Age \<18 y.o.;
- Hypercapnia with respiratory acidosis (PaCO2 \> 45 mmHg with pH \< 7.35);
- History of fever in the previous 4 days;
- White blood cell count \> 12.000;
- Increased procalcitonin serum levels;
- Consolidative areas at chest radiograph;
- Hypotension (systolic blood pressure \< 85 mmHg);
- Cardiogenic shock;
- Right ventricular (RV) dysfunction;
- Previous cardiac surgery,
- Glasgow Coma Scale score ≤ 8 points;
- Impaired ability to protect the airway from aspiration;
- Orotracheal intubation needed due to cardiopulmonary resuscitation maneuvers;
- Respiratory arrest;
- Severe hemodynamic instability;
- Facial trauma, burns, recent facial surgery or facial anatomy which prevents from the application of the NPPV interface to patient's face.
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.