High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: High SpO2; Other: Low SpO2

• Registration Number: NCT02518828
• Lead Sponsor: University of Alberta

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-10
• Study Start: 2017-01
• Status Verified: 2017-11
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

• on home oxygen
• known prior hypercapnic failure (PaCO2 >50 mmHg)
• asthma
• primary pulmonary hypertension,
• patients who require urgent positive pressure ventilation or intubation
• patients on >10 L/min oxygen

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High SpO2	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%
Low SpO2	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%

Primary Outcome Measures

Name	Time	Method
Change in NT-proBNP from baseline to 72 hours	72 hours

Secondary Outcome Measures

Name	Time	Method
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	All cause mortality, HF readmission, days alive and out of hospital
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

Trial Locations

Locations (1)

University of Alberta Hospital / Mazankowski Alberta Heart Institute; 🇨🇦 Edmonton, Alberta, Canada