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Device

High-Flow Air + Oxygen Therapy for Lung Disease

N/A

Recruiting

Led By Sonye Danoff, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a peripheral blood saturation level above 80% with room air while seated

Male or female, aged greater or equal to 30 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 20 minutes

Awards & highlights

Study Summary

This trial is testing if high flow air can help COPD, Interstitial Lung Disease, and Pulmonary Hypertension patients breathe better by reducing the amount of oxygen required.

Who is the study for?

This trial is for adults aged 30 or older with certain lung diseases like COPD, ILD, or PH who need oxygen therapy at rest. They must have a history of stable heart rate and blood pressure, not be pregnant or breastfeeding, and haven't had recent cardiovascular issues.Check my eligibility

What is being tested?

The study compares standard oxygen therapy to two new methods: one combines high-flow air with oxygen, and the other alternates between them. The goal is to see which method best maintains an oxygen saturation level of 95% during rest.See study design

What are the potential side effects?

Potential side effects may include discomfort from nasal delivery devices, dryness in the nose or throat from airflow, possible shortness of breath if settings are not optimal, and fatigue due to participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood oxygen level is above 80% without extra oxygen.

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I am 30 years old or older.

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I can breathe on my own without assistance when sitting.

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I have been diagnosed with COPD, ILD, or PH based on tests.

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My heart rate and blood pressure are within normal ranges.

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I need oxygen therapy at 1-4 L/min when resting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 20 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 20 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effectiveness of partial replacement of concentrated oxygen by high flow ambient air for Long Term Oxygen Therapy

Secondary outcome measures

Dyspnea relief achieved with of partial replacement of concentrated oxygen by high flow ambient air for Long Term Oxygen Therapy

Trial Design

12Treatment groups

Experimental Treatment

Group I: Baseline followed by intervention 2fExperimental Treatment2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min).

Group II: Baseline followed by intervention 2eExperimental Treatment2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min).

Group III: Baseline followed by intervention 2dExperimental Treatment2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min).

Group IV: Baseline followed by intervention 2cExperimental Treatment2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min).

Group V: Baseline followed by intervention 2bExperimental Treatment2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min).

Group VI: Baseline followed by intervention 2aExperimental Treatment2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min).

Group VII: Baseline followed by intervention 1fExperimental Treatment2 Interventions

Group VIII: Baseline followed by intervention 1eExperimental Treatment2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min).

Group IX: Baseline followed by intervention 1dExperimental Treatment2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min).

Group X: Baseline followed by intervention 1cExperimental Treatment2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min).

Group XI: Baseline followed by intervention 1bExperimental Treatment2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min).

Group XII: Baseline followed by intervention 1aExperimental Treatment2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min).

0 / 6Eligibility criteria met