RecruitingPhase 2Phase 3NCT05613218

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

Sponsor

Copenhagen University Hospital, Hvidovre

Enrollment

122 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Heart Failure Hypoxemia Pulmonary Congestion

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether carefully targeting a specific blood oxygen level (oxygen saturation) with supplemental oxygen improves outcomes in people admitted to hospital with acute heart failure and fluid buildup in the lungs (pulmonary congestion). **You may be eligible if...** - You are 18 years or older - You have had sudden or worsening shortness of breath (within days) - Your blood oxygen level is below 92% or you already need supplemental oxygen - You show signs of fluid in your lungs (crackling lung sounds, chest X-ray or ultrasound showing congestion) **You may NOT be eligible if...** - More than 4 hours have passed since your hospital admission before the study starts - You are suspected of having an infection or sepsis - You have known severe lung disease - Your blood pressure is very low (below 90 mmHg systolic) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOxygen

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.