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Oxygen Targets in Acute Heart Failure With Pulmonary Congestion

RECRUITINGPhase 2/3Sponsored by Copenhagen University Hospital, Hvidovre
Actively Recruiting
PhasePhase 2/3
SponsorCopenhagen University Hospital, Hvidovre
Started2024-02-01
Est. completion2026-02-28
Eligibility
Age18 Years+
Healthy vol.Accepted

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. 1. Liberal oxygenation group = SpO2 target of 96%. 2. 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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

1. Age ≥ 18 years
2. Acute (within minutes to days) onset or worsening of subjective dyspnea
3. Oxygen saturation \<92% (on arterial blood gas) or need of oxygen
4. At 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-lines

Exclusion Criteria:

1. More than 4 hours from hospital admission to randomization
2. Suspected infection or sepsis
3. Known severe pulmonary disease
4. Systolic blood pressure \<90 mmHg

Conditions4

Acute Heart FailureHeart DiseaseHypoxemiaPulmonary Congestion

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