High-Flow Air + Oxygen Therapy for Lung Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests different methods of providing oxygen therapy to individuals with specific lung diseases, such as COPD, ILD, or Pulmonary Hypertension. The goal is to determine if adding high-flow air to oxygen therapy (nasal delivery of high-flow air and oxygen therapy) helps maintain a healthy oxygen level more effectively than oxygen alone. Participants will try various combinations of oxygen and high-flow air delivered nasally while resting. Suitable candidates have a diagnosis of one of these lung diseases and require oxygen therapy at rest. As an unphased trial, this study offers a unique opportunity to explore innovative oxygen therapy methods that could enhance quality of life.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot participate if you've been treated with another investigational drug or intervention within the last three months.
What prior data suggests that this method is safe for lung disease patients?
Research has shown that high-flow nasal cannula (HFNC) therapy is safe and well-tolerated for individuals with various breathing problems. One study found that HFNC is effective and safe for those with chronic obstructive pulmonary disease (COPD), regardless of whether their carbon dioxide levels are normal or elevated. Another study confirmed that HFNC is commonly used to treat severe respiratory issues in critically ill patients and is generally well-tolerated. Although the details of this new trial are not provided, existing research suggests that high-flow air and oxygen therapy is safe for individuals.12345
Why are researchers excited about this trial?
Researchers are excited about the High-Flow Air + Oxygen Therapy for lung disease because it offers a novel delivery method that combines high-flow air with oxygen, potentially providing faster and more effective relief for patients. Unlike traditional oxygen therapy, which typically uses a constant flow of low oxygen levels, this approach uses high-flow rates and pulsed delivery, enhancing oxygen uptake and reducing work for the lungs. This method could lead to improved breathing comfort and better overall lung function, making it a promising alternative to standard oxygen therapy.
What evidence suggests that this trial's treatments could be effective for lung disease?
Research has shown that high-flow nasal cannula (HFNC) oxygen therapy can aid in managing lung conditions such as COPD, ILD, and PH. Studies indicate that HFNC stabilizes vital signs and improves breathing in individuals with respiratory issues. For those with COPD, it lowers breathing rates and reduces carbon dioxide levels in the blood while enhancing lung function. Additionally, research suggests it may extend the lives of people with severe breathing problems. HFNC can also facilitate exercise and daily activities for those with lung diseases. Overall, these findings suggest that HFNC with oxygen effectively relieves low blood oxygen levels in patients with these conditions. This trial will evaluate different methods of delivering high-flow air and oxygen therapy to identify the most effective approach for improving patient outcomes.16789
Who Is on the Research Team?
Sonye Danoff, MD, PhD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Titration
Participants perform baseline titration with oxygen only to determine the required oxygen flow rate to maintain 95% SpO2.
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
12
Treatment groups
Experimental Treatment
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
American College of Chest Physicians
Collaborator
CHEST Foundation
Collaborator
Citations
Effectiveness of high-flow nasal cannula oxygen therapy ...
This study revealed that HFNC oxygen therapy was beneficial even in the patients with acute hypercapnic respiratory failure. The vital signs were stabilized and ...
A Comprehensive Review on High-Flow Nasal Cannula ...
Notably, in patients with COVID-19-related respiratory failure, HFNO has shown promising survival benefits, with some studies reporting survival ...
Physiological effects and clinical evidence of high-flow ...
Nasal high flow oxygen therapy in patients with COPD reduces respiratory rate and tissue carbon dioxide while increasing tidal and end-expiratory lung ...
4.
journals.lww.com
journals.lww.com/anesthesia-analgesia/fulltext/2025/11000/high_flow_nasal_oxygen_versus_mechanical.27.aspxHigh-Flow Nasal Oxygen versus Mechanical Ventilation... ...
Based on these data, we estimated a 95% success rate both for HFNO and laryngeal mask ventilation. For a unilateral 95% CI and a power of 90%, 82 was the ...
5.
journalpulmonology.org
journalpulmonology.org/pt-clinical-evidence-on-high-flow-articulo-S0873215913000391Clinical evidence on high flow oxygen therapy and active ...
This study shows that the use of high-flow oxygen via both transtracheal catheter and nasal prongs significantly increased exercise tolerance in COPD patients ...
High-flow nasal cannula for respiratory failure in adult ...
HFNC has been successfully used in critically ill patients with several conditions, such as hypoxemic respiratory failure, hypercapneic ...
SEPAR Position Paper on the Use of High Flow Nasal ...
Efficacy and tolerability of high-flow nasal cannula oxygen therapy for hypoxemic respiratory failure in patients with interstitial lung disease ...
High-flow oxygen therapy and other inhaled ...
In this Series paper, we review the current evidence for the use of high-flow oxygen therapy, inhaled gases, and aerosols in the care of critically ill ...
Efficacy and safety of nasal high-flow oxygen in COPD patients
Summary. Short-term nasal highflow oxygen therapy (HFOT) is safe and efficacious in normocapnic and hypercapnic COPD patients.
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