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

NCT ID: NCT02518828

Last Updated: 2018-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-07-31

Brief Summary

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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

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Patients will be randomized to either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen after informed consent.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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%

Group Type ACTIVE_COMPARATOR

High SpO2

Intervention Type OTHER

SpO2 range ≥96%

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%

Group Type ACTIVE_COMPARATOR

Low SpO2

Intervention Type OTHER

SpO2 range 90-92%

Interventions

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High SpO2

SpO2 range ≥96%

Intervention Type OTHER

Low SpO2

SpO2 range 90-92%

Intervention Type OTHER

Eligibility Criteria

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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)
* asthma
* primary pulmonary hypertension,
* patients who require urgent positive pressure ventilation or intubation
* patients on \>10 L/min oxygen
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

Alberta Innovates Health Solutions

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin Ezekowitz, MBBCH

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta Hospital / Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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HiLo-HF- 2 Pilot Trial

Identifier Type: -

Identifier Source: org_study_id

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