Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT05613218
Brief 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.
Detailed Description:
Background:
One million hospitalizations occur each year with a primary diagnosis of acute heart failure in the USA, with comparable numbers in Europe. Most patients with acute heart failure are treated with supplemental oxygen during hospitalization and guidelines recommend initiation of oxygen therapy if SpO2 \<90% (class I, level C). However, no clinical trials of oxygen targets in humans with acute heart failure investigating clinically relevant endpoints have been performed.
Primary objective:
To investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure.
Hypothesis:
Restrictive oxygenation is associated with improved clinical outcome compared to liberal oxygenation.
Design: Investigator-initiated, prospective, randomized, blinded, multi-center, controlled trial.
Intervention:
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%.
Patients will have nasal cannula or oxygen mask placed as the usual care, and oxygen is titrated to the prespecified target range.
Consented patients will be randomly allocated to study groups via the automated 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 oxygen-administration.
The intervention-phase will be 24 h, and hereafter oxygen therapy will be at the discretion of the treating physician.
Study:
NCT05613218
Study Brief:
Protocol Section:
NCT05613218