Clinical Research Directory
Browse clinical research sites, groups, and studies.
Oxygen Targets in Acute Heart Failure With Pulmonary Congestion
Sponsor: Copenhagen University Hospital, Hvidovre
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.
Official title: Restrictive Versus Liberal Oxygenation Targets in Patients With Acute Heart Failure and Pulmonary Congestion - a Randomized Clinical Pilot-trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
122
Start Date
2024-02-01
Completion Date
2026-04-30
Last Updated
2025-12-09
Healthy Volunteers
No
Interventions
Oxygen
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)
Bispebjerg Hospital
Copenhagen, Denmark
Amager-Hvidovre Hospital
Copenhagen, Denmark