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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05414370
Other study ID # 18129MS-AS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 2, 2022
Est. completion date December 30, 2024

Study information

Verified date January 2024
Source Belfast Health and Social Care Trust
Contact Danny McAuley, MD
Phone +442890 972144
Email d.f.mcauley@qub.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 53
Est. completion date December 30, 2024
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design


Intervention

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.
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.

Locations

Country Name City State
United Kingdom Belfast Health and Social Care Trus Belfast

Sponsors (1)

Lead Sponsor Collaborator
Belfast Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bronchoalveolar lavage Interleukin-8 (IL-8) concentration To determine the effects of hyperoxia on alveolar inflammatory response 6 hours post-intervention
Secondary Bronchoalveolar lavage cytokines including but not limited to tumour necrosis factor alpha, IL-1 beta and IL-6 To determine the effects of hyperoxia on alveolar inflammatory response biomarkers 6 hours post-intervention
Secondary Bronchoalveolar lavage proteases and anti-proteases including but not limited to Matrix Metalloproteinases (MMP-2, MMP-8, MMP-9 and MMP-11), Tissue Inhibitors of Metalloproteinase (TIMPs 1-2) and neutrophil elastase To determine the effects of hyperoxia on alveolar protease and antiprotease activity 6 hours post-intervention
Secondary Bronchoalveolar lavage white cell differential counts (total cell count, neutrophils, macrophages and lymphocytes) To determine the effects of hyperoxia on alveolar cell populations 6 hours post-intervention
Secondary Plasma cytokines including but not limited to IL-8, tumour necrosis factor alpha, IL-1 beta and IL-6 To determine the effects of hyperoxia on plasma inflammatory response biomarkers 6 and 24 hours post-intervention
Secondary Bronchoalveolar lavage soluble programmed cell death receptor (SP-D) To determine the effects of hyperoxia on alveolar epithelial and endothelial function 6 hours post-intervention
Secondary Bronchoalveolar lavage total protein To determine the effects of hyperoxia on alveolar epithelial and endothelial function 6 hours post-intervention
Secondary Bronchoalveolar lavage receptor for advanced glycation end-products (RAGE) To determine the effects of hyperoxia on alveolar epithelial and endothelial function 6 hours post-intervention
Secondary Bronchoalveolar lavage 4-hydroxy-2-nonenal (4-HNE) To determine the effects of hyperoxia on oxidative stress 6 hours post-intervention
Secondary Bronchoalveolar lavage oxidised low density lipoprotein (oxLDL) To determine the effects of hyperoxia on oxidative stress 6 hours post-intervention
Secondary Plasma advanced glycation end products (AGE) To determine the effects of hyperoxia on oxidative stress 6 and 24 hours post-intervention
Secondary Plasma oxidised low density lipoprotein (oxLDL) To determine the effects of hyperoxia on oxidative stress 6 and 24 hours post-intervention
Secondary Plasma 4-hydroxy-2-nonenal (4-HNE) To determine the effects of hyperoxia on oxidative stress 6 and 24 hours post-intervention
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