Oxygen Targets in Acute Heart Failure With Pulmonary Congestion

• Status: Not yet recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Copenhagen University Hospital, Hvidovre
• Collaborator: Bispebjerg Hospital

Criteria

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