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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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 environment. Furthermore, hyperoxia related complications following cardiac arrest, myocardial infarction and stroke have also been reported. The underlying mechanisms of hyperoxia mediated injury remain poorly understood and there are currently no human in vivo studies exploring the relationship between hyperoxia and direct pulmonary injury and inflammation as well as distant organ injury. The current trial is a mechanistic study designed to evaluate the effects of prolonged administration of high-flow oxygen (hyperoxia) on pulmonary and systemic inflammation. The study is a randomised, double-blind, placebo-controlled trial of high-flow nasal oxygen therapy versus matching placebo (synthetic medical air). We will also incorporate a model of acute lung injury induced by inhaled endotoxin (LPS) in healthy human volunteers. Healthy volunteers will undergo bronchoalveolar lavage (BAL) at 6 hours post-intervention to enable measurement of pulmonary and systemic markers of inflammation, oxidative stress and cellular injury.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 1\. Healthy non-smoking subjects less than 45 years of age and BMI \< 29 kg/m²

Locations
Other Locations
United Kingdom
Belfast Health and Social Care Trus
RECRUITING
Belfast
Contact Information
Primary
Danny McAuley, MD
d.f.mcauley@qub.ac.uk
+442890 972144
Backup
Dermot Linden, PhD
dlinden02@qub.ac.uk
07812008626
Time Frame
Start Date: 2022-12-02
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 53
Treatments
Active_comparator: Liquid medical oxygen
Liquid medical oxygen will be administered using high-flow nasal cannula delivery system.
Placebo_comparator: Synthetic medical air
Synthetic medical air will be administered using high-flow nasal cannula delivery system.
Sponsors
Leads: Belfast Health and Social Care Trust

This content was sourced from clinicaltrials.gov