Effects of high-flow oxygen on lung inflammation and injury
Effects of Hyperoxia Induced Pulmonary Inflammation and Organ Injury in a Human in Vivo Model
This study tests whether using high-flow oxygen helps reduce lung inflammation and injury in people with breathing problems compared to a placebo treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Belfast Health and Social Care Trust Academic / other |
| Locations | 1 site (Belfast) |
| Trial ID | NCT05414370 on ClinicalTrials.gov |
What this trial studies
This study investigates how prolonged exposure to high-flow oxygen affects inflammation and injury in the lungs and other organs. It is a randomized, double-blind, placebo-controlled trial comparing high-flow nasal oxygen therapy to a placebo of synthetic medical air. The study also includes a model of acute lung injury induced by inhaled endotoxin to better understand the mechanisms of hyperoxia-related complications. The goal is to clarify the relationship between high oxygen levels and pulmonary injury in a human setting.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy non-smoking individuals under 45 years of age with a BMI less than 29 kg/m².
Not a fit: Patients with a history of respiratory conditions, smoking, or those who are pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of oxygen therapy in critical care settings, potentially reducing complications associated with hyperoxia.
How similar studies have performed: While there is limited research on hyperoxia's effects in humans, this study aims to fill a gap in understanding, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy non-smoking subjects less than 45 years of age and BMI \< 29 kg/m² Exclusion Criteria: 1. Age \< 18 years 2. On concomitant medications including over the counter medications excluding oral contraception and paracetamol 3. Previous adverse reactions to LPS, lignocaine or sedative agents 4. Pregnant or Breast-Feeding 5. Participation in a clinical trial of an investigational medicinal product within 30 days 6. Consent declined 7. History of asthma or other respiratory conditions 8. Smoking/ e cigarette use 9. Marijuana use or other inhaled products with or without nicotine in the last 3 months 10. Alcohol abuse, as defined by the Alcohol Use Disorders Identification Test (AUDIT) 11. Subjects with history of prior conventional cigarette (\> 100 cigarettes lifetime and smoking within 6 months) or electronic cigarette use.
Where this trial is running
Belfast
- Belfast Health and Social Care Trus — Belfast, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Danny McAuley, MD — Queen's University, Belfast
- Study coordinator: Danny McAuley, MD
- Email: d.f.mcauley@qub.ac.uk
- Phone: +442890 972144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.