Status:
RECRUITING
Hyperoxia Induced Pulmonary Inflammation and Organ Injury: a Human in Vivo Model
Lead Sponsor:
Belfast Health and Social Care Trust
Conditions:
Oxygen Toxicity
Pulmonary Injury
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Oxygen is the most commonly administered therapy in critical illness. Accumulating evidence suggests that patients often achieve supra-physiological levels of oxygenation in the critical care environm...
Eligibility Criteria
Inclusion
- 1\. Healthy non-smoking subjects less than 45 years of age and BMI \< 29 kg/m²
Exclusion
- Age \< 18 years
- On concomitant medications including over the counter medications excluding oral contraception and paracetamol
- Previous adverse reactions to LPS, lignocaine or sedative agents
- Pregnant or Breast-Feeding
- Participation in a clinical trial of an investigational medicinal product within 30 days
- Consent declined
- History of asthma or other respiratory conditions
- Smoking/ e cigarette use
- Marijuana use or other inhaled products with or without nicotine in the last 3 months
- Alcohol abuse, as defined by the Alcohol Use Disorders Identification Test (AUDIT)
- Subjects with history of prior conventional cigarette (\> 100 cigarettes lifetime and smoking within 6 months) or electronic cigarette use.
Key Trial Info
Start Date :
December 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05414370
Start Date
December 2 2022
End Date
December 30 2024
Last Update
January 29 2024
Active Locations (1)
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1
Belfast Health and Social Care Trus
Belfast, United Kingdom