High-Flow Air + Oxygen Therapy for Lung Disease

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnancy, Unstable angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

11 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is meant to compare the amount of oxygen required for hypoxemia relief between current standard of care (oxygen only) and oxygen with the addition of high flow air for Chronic Obstructive Pulmonary Disease (COPD), Interstitial Lung Disease (ILD), and Pulmonary Hypertension (PH) patients during rest. Subjects will be titrated from 0 L/min until they maintain 95% SpO2 for each of the following delivery methods: 1. Pulses of pure oxygen (control) 2. Constant high flow air with pulses of pure oxygen 3. Out of phase pulses of high flow air and pure oxygen

Research Team

Sonye Danoff, MD, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

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

You have had a pulmonary function test in the last three months.

I am 30 years old or older.

Exclusion Criteria

I have had recent heart or stroke issues.

Pregnancy or lactation

Treatment with another investigational drug or other intervention within three months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Titration

Participants perform baseline titration with oxygen only to determine the required oxygen flow rate to maintain 95% SpO2.

Approximately 15 minutes

1 visit (in-person)

Intervention

Participants are titrated with six different delivery methods, including Out-of-Phase pulsed high-flow air and oxygen, and Continuous high-flow air with pulsed oxygen.

4-5 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Nasal Delivery of High-Flow Air and Oxygen Therapy
• Nasal Delivery of Oxygen Therapy

Trial Overview 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.

Participant Groups

Group I: Baseline followed by intervention 2f Experimental Treatment 2 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 2e Experimental Treatment 2 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 2d Experimental Treatment 2 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 2c Experimental Treatment 2 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 2b Experimental Treatment 2 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 2a Experimental Treatment 2 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 1f Experimental Treatment 2 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 VIII: Baseline followed by intervention 1e Experimental Treatment 2 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 1d Experimental Treatment 2 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 1c Experimental Treatment 2 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 1b Experimental Treatment 2 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 1a Experimental Treatment 2 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).

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

American College of Chest Physicians

Collaborator

Trials

10

Recruited

2,200+

CHEST Foundation

Collaborator

Trials

4

Recruited

190+