High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in NT-proBNP from baseline to 72 hours
Study Overview
Brief Summary
The primary objective of this pilot trial is to determine whether inpatients presenting to the Emergency Department (ED) with symptoms suggestive of Acute Heart Failure (AHF), who receive supplemental oxygen adjusted at either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen saturation level, leads to greater reduction in N-terminal-proBNP (NT-proBNP) at 72 hours.
Detailed Description
Patients will be randomized to either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen after informed consent.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •>40 years of age presenting to the ED with AHF
- •objective finding of HF (BNP >400 pg/ml or Chest X-Ray with pulmonary congestion)
- •plan to admit with primary diagnosis as HF
- •must be able to be randomized within 16 hours of presenting to the ED
- •provided written informed consent
Exclusion Criteria
- •on home oxygen
- •known prior hypercapnic failure (PaCO2 >50 mmHg)
- •primary pulmonary hypertension,
- •patients who require urgent positive pressure ventilation or intubation
- •patients on >10 L/min oxygen
Arms & Interventions
High SpO2
In the high SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range ≥96%
Intervention: High SpO2 (Other)
Low SpO2
In the low SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range 90-92%
Intervention: Low SpO2 (Other)
Outcomes
Primary Outcomes
Change in NT-proBNP from baseline to 72 hours
Time Frame: 72 hours
Secondary Outcomes
- Hochberg endpoint (combination of NT-proBNP and PGA)(72 hours)
- Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours)(72 hours)
- Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours(72 hours)
- Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours(72 hours)
- 30-day clinical events(30 days)
- Average z-score from the combination of these outcomes: PGA, NT-proBNP, 7-day WHF, 30-day mortality and re-hospitalization(30 days)
- Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours(72 hours)
- Number of worsening heart failure (WHF) events(7 days)