Overview

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?

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