Acute Heart Failure, Hypoxemia, Pulmonary Congestion
Conditions
Keywords
acute heart failure, Pulmonary edema, Oxygen, Pulmonary congestion
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.
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.
Sponsors
Copenhagen University Hospital, Hvidovre
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Oxygen-delivery will be given through a robot, which adjusts oxygen-flow towards a given oxygen-saturation target. The robots monitor will be turned of during the intervention and will only alarm in case of clinically relevant hypoxemia.
Intervention model description
1:1 allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Acute (within minutes to days) onset or worsening of subjective dyspnea 3. Oxygen saturation \<92% (on arterial blood gas) or need of oxygen 4. 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
Exclusion criteria
1. More than 4 hours from hospital admission to randomization 2. Suspected infection or sepsis 3. Known severe pulmonary disease 4. Systolic blood pressure \<90 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary parenchymal fluid content after 24 hours | 24 hours | Pulmonary parenchymal fluid content after 24 hours preceded by 10 minutes without oxygen-supplementation assessed noninvasively by the remote dielectric sensing (ReDS) device (Sensible Medical, Netanya, Israel) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 4) Change from baseline in log-transformed biomarkers N-Terminal Pro-Brain Natriuretic Peptide to 24 hours from admission. | 24 hours | — |
| 5) Arterial blood gas concentration after 24 hours preceded by 10 minutes without oxygen-supplementation. | 24 hours | — |
| All-cause mortality | 30 days | Death from all causes |
| Days alive out-of-hospital | 30 days | — |
| Time to freedom from oxygen-supplementation | 48 hours | — |
| Global longitudinal strain of the right ventricle | 24 hours | — |
| Tricuspid annular plane systolic excursion | 24 hours | — |
Countries
Denmark
Contacts
STUDY_CHAIRJens Hove, MD, PhD
Copenhagen University Hospital Amager-Hvidovre Department of Cardiology
PRINCIPAL_INVESTIGATORJohannes Grand, MD, PhD
Copenhagen University Hospital Amager-Hvidovre Department of Cardiology
STUDY_DIRECTORIda Taraldsen, MD
Copenhagen University Hospital Amager-Hvidovre Department of Cardiology
Outcome results
None listed