Oxygen Targets in Acute Heart Failure With Pulmonary Congestion
Restrictive Versus Liberal Oxygenation Targets in Patients With Acute Heart Failure and Pulmonary Congestion - a Randomized Clinical Pilot-trial
Copenhagen University Hospital, Hvidovre
122 participants
Feb 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Age ≥ 18 years
- Acute (within minutes to days) onset or worsening of subjective dyspnea
- Oxygen saturation \<92% (on arterial blood gas) or need of oxygen
- At least one of the following clinical or radiological signs of congestion:
- \. Pulmonary rales 2. Chest X-ray or CT with pulmonary congestion 3. Lung ultrasound with multiple B-lines
Exclusion Criteria4
- More than 4 hours from hospital admission to randomization
- Suspected infection or sepsis
- Known severe pulmonary disease
- Systolic blood pressure \<90 mmHg
Interventions
Patients will have nasal cannula or oxygen mask placed as the usual standard of care. Patients will be screened and randomized in the emergency department to either liberal or restrictive oxygenation after providing informed written consent and oxygen is titrated to the prespecified target range using an automated feedback device (O2MATIC). Consented patients will be randomly allocated to study groups via the web-based system within REDCap. The allocation will be concealed. Time at randomization will be considered as study time zero (T0). All patients will receive usual standard of care except for their O2 management. The intervention will last for 24 h. After 24 h, patients will be switched over to usual care for oxygen therapy. If the treating physician thinks, that the patient need another oxygenation target and it is thought to be harmful to continue with the allocated target, the intervention-phase can be stopped prematurely.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05613218