Restrictive Versus Liberal Oxygenation Targets in Patients With Acute Heart Failure and Pulmonary Congestion - a Randomized Clinical Pilot-trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

⁃ 1\. Pulmonary rales 2. Chest X-ray or CT with pulmonary congestion 3. Lung ultrasound with multiple B-lines

Locations
Other Locations
Denmark
Amager-Hvidovre Hospital
RECRUITING
Copenhagen
Bispebjerg Hospital
RECRUITING
Copenhagen
Contact Information
Primary
Johannes Grand, MD, Phd
johannes.grand@regionh.dk
+4535453545
Backup
Ida Taraldsen, MD
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 122
Treatments
Active_comparator: Liberal oxygenation group
SpO2 target of 96%
Active_comparator: Restrictive oxygenation group
SpO2 target of 90%.
Related Therapeutic Areas
Sponsors
Collaborators: Bispebjerg Hospital
Leads: Copenhagen University Hospital, Hvidovre

This content was sourced from clinicaltrials.gov