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NCT05613218
Oxygen Targets in Acute Heart Failure With Pulmonary Congestion
Conditions: Acute Heart Failure, Pulmonary Congestion, Hypoxemia
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2, PHASE3
Enrollment: 122
Sponsor: Copenhagen University Hospital, Hvidovre
Location: Denmark
Summary
This investigator-initiated, prospective, randomized, blinded, multi-center, controlled trial will investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure with pulmonary congestion.Patients will be randomized 1:1 in the emergency department to either liberal or restrictive oxygenation after providing informed written consent.Liberal oxygenation group = SpO2 target of 96%.Restrictive oxygenation group = SpO2 target of 90%.The allocation will be concealed through the use of an oxygen-delivery robot, termed O2MATIC.
The study will include 122 patients.
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 yearsAcute (within minutes to days) onset or worsening of subjective dyspneaOxygen saturation <92% (on arterial blood gas) or need of oxygenAt least one of the following clinical or radiological signs of congestion:1. Pulmonary rales 2. Chest X-ray or CT with pulmonary congestion 3. Lung ultrasound with multiple B-linesExclusion Criteria:More than 4 hours from hospital admission to randomizationSuspected infection or sepsisKnown severe pulmonary diseaseSystolic blood pressure <90 mmHg
Source: ClinicalTrials.gov (NCT05613218). StuddyBuddy aggregates publicly available trial information.