NCT05414370

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Belfast Health and Social Care Trust · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oxygen Toxicity
• Pulmonary Injury
• Acute Lung Injury

Interventions

Type	Name	Description
DRUG	Liquid oxygen	Liquid medical oxygen will be administered for 6 hours using high-flow nasal cannula delivery system with an Fi02 of 100% and flow rate of 60 litres per minute.
DRUG	medical air	Synthetic medical air will be administered for 6 hours using high-flow nasal cannula delivery system with a flow rate of 60 litres per minute.

Timeline

• Start date: 2022-12-02
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2022-06-10
• Last updated: 2024-01-29

Locations

1 site across 1 country: United Kingdom