Hyperoxia Induced Pulmonary Inflammation and Organ Injury: a Human in Vivo Model

Launched by BELFAST HEALTH AND SOCIAL CARE TRUST · Jun 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of high-flow oxygen therapy, also known as hyperoxia, on lung inflammation and possible injury in healthy volunteers. Researchers want to understand how receiving too much oxygen can affect the lungs and other organs, especially since this can happen frequently in critical care settings. The trial is designed as a randomized, double-blind study, meaning that some participants will receive the high-flow oxygen while others will get a placebo, which is a substance that looks like oxygen but has no therapeutic effect. Participants will also experience a controlled lung injury to help measure the effects of the oxygen treatment.

To be eligible for this study, participants must be healthy, non-smoking individuals under 45 years old and have a body mass index (BMI) under 29. Those interested should know that certain health conditions, recent medications, and lifestyle choices, such as smoking or using marijuana, may disqualify them from participating. If selected, participants can expect a thorough evaluation of their lung function and inflammation levels after the oxygen treatment, helping researchers gain valuable insights into how excessive oxygen may impact health.

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Eligibility 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.