Oxygen Savings With Administered Oxygen and High Flow Ambient Air At Rest

NCT04170062 | Completed

• 1 other identifier: IRB00206318
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.Pulses of pure oxygen (control)
2. 2.Constant high flow air with pulses of pure oxygen
3. 3.Out of phase pulses of high flow air and pure oxygen

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Pulmonary Fibrosis; Hypoxemia; Dyspnea; Oxygen Inhalation Therapy

Outcome Measures

Primary Outcomes (1)

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

  This will be assessed using the difference between the oxygen delivery systems (pure oxygen and mixed high-flow air with oxygen) in the L/min flow of oxygen required for a participant to reach steady state at greater than or equal to 95% pulse oxygenation.

  up to 20 minutes

Secondary Outcomes (1)

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

  Approximately 15 minutes

Study Arms (12)

Baseline followed by intervention 1a

EXPERIMENTAL

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).

Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy

Baseline followed by intervention 1b

EXPERIMENTAL

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).

Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy

Baseline followed by intervention 1c

EXPERIMENTAL

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).

Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy

Baseline followed by intervention 1d

EXPERIMENTAL

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).

Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy

Baseline followed by intervention 1e

EXPERIMENTAL

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).

Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy

Baseline followed by intervention 1f

EXPERIMENTAL

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).

Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy

Baseline followed by intervention 2a

EXPERIMENTAL

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).

Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy

Baseline followed by intervention 2b

EXPERIMENTAL

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).

Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy

Baseline followed by intervention 2c

EXPERIMENTAL

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).

Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy

Baseline followed by intervention 2d

EXPERIMENTAL

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).

Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy

Baseline followed by intervention 2e

EXPERIMENTAL

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).

Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy

Baseline followed by intervention 2f

EXPERIMENTAL

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).

Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy

Interventions

Nasal Delivery of High-Flow Air and Oxygen Therapy DEVICE

They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.

Baseline followed by intervention 1a; Baseline followed by intervention 1b; Baseline followed by intervention 1c; Baseline followed by intervention 1d; Baseline followed by intervention 1e; Baseline followed by intervention 1f; Baseline followed by intervention 2a; Baseline followed by intervention 2b; Baseline followed by intervention 2c; Baseline followed by intervention 2d; Baseline followed by intervention 2e; Baseline followed by intervention 2f

Nasal Delivery of Oxygen Therapy DEVICE

They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.

Baseline followed by intervention 1a; Baseline followed by intervention 1b; Baseline followed by intervention 1c; Baseline followed by intervention 1d; Baseline followed by intervention 1e; Baseline followed by intervention 1f; Baseline followed by intervention 2a; Baseline followed by intervention 2b; Baseline followed by intervention 2c; Baseline followed by intervention 2d; Baseline followed by intervention 2e; Baseline followed by intervention 2f

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged greater or equal to 30 years old
• Require Long Term Oxygen Therapy between 1 L/min and 4 L/min while at rest
• Have a peripheral blood saturation level above 80% with room air while seated
• Tolerate breathing while seated in room air
• Diagnosed with one of the following respiratory diseases: COPD (40% \< Forced Expiratory Volume (FEV1) \< 80% confirmed from pulmonary function test (PFT) within the last year), ILD (Confirmed with radiographic imaging), PH (Confirmed with radiographic imaging)
• Normal heart rate and blood pressure (Resting Heart Rate \<120 bpm, Systolic BP \<180 mmHg, Diastolic BP \<100mmHg)
• PFT taken in the last three months

You may not qualify if:

• Pregnancy or lactation
• Exacerbation that has resolved within the past 28 days
• Treatment with another investigational drug or other intervention within three months
• Has any of the following: unstable angina, recent revascularization, recent history of cerebrovascular accident

Sponsors & Collaborators

• Johns Hopkins University: lead
• American College of Chest Physicians: collaborator

Study Sites (2)

The Johns Hopkins Hospital

Baltimore, Maryland, 212187, United States

Location

Johns Hopkins Hospital Bayview Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Pulmonary Fibrosis; Hypoxia; Dyspnea

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Study Officials

• Sonye Danoff, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Order of treatments tested will be randomized and only known to the person administering the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: December 15, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 16, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)