An interventional study of Liquid oxygen and medical air in Oxygen Toxicity, Pulmonary Injury and Acute Lung Injury, sponsored by Belfast Health and Social Care Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by Belfast Health and Social Care Trust · Not applicable, Interventional, and Basic science
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.
382 studies on the registry are indexed under Acute Lung Injury; 73 are open to participants now.
This study's planned enrollment of 53 is below the median of 60 across 227 interventional studies indexed under Acute Lung Injury.
Browse Acute Lung Injury studies →Belfast Health and Social Care Trust is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
Compared within Acute Lung Injury, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Injury. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Liquid medical oxygen will be administered using high-flow nasal cannula delivery system.
Drug: Liquid oxygen
Synthetic medical air will be administered using high-flow nasal cannula delivery system.
Drug: medical air
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.
Also known as: Liquid medical oxygen
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.
Also known as: Synthetic medical air
Bronchoalveolar lavage Interleukin-8 (IL-8) concentration
To determine the effects of hyperoxia on alveolar inflammatory response
Time frame: 6 hours post-intervention
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
Time frame: 6 hours post-intervention
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
Time frame: 6 hours post-intervention
Bronchoalveolar lavage white cell differential counts (total cell count, neutrophils, macrophages and lymphocytes)
To determine the effects of hyperoxia on alveolar cell populations
Time frame: 6 hours post-intervention
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
Time frame: 6 and 24 hours post-intervention
Bronchoalveolar lavage soluble programmed cell death receptor (SP-D)
To determine the effects of hyperoxia on alveolar epithelial and endothelial function
Time frame: 6 hours post-intervention
Bronchoalveolar lavage total protein
To determine the effects of hyperoxia on alveolar epithelial and endothelial function
Time frame: 6 hours post-intervention
Bronchoalveolar lavage receptor for advanced glycation end-products (RAGE)
To determine the effects of hyperoxia on alveolar epithelial and endothelial function
Time frame: 6 hours post-intervention
Bronchoalveolar lavage 4-hydroxy-2-nonenal (4-HNE)
To determine the effects of hyperoxia on oxidative stress
Time frame: 6 hours post-intervention
Bronchoalveolar lavage oxidised low density lipoprotein (oxLDL)
To determine the effects of hyperoxia on oxidative stress
Time frame: 6 hours post-intervention
Plasma advanced glycation end products (AGE)
To determine the effects of hyperoxia on oxidative stress
Time frame: 6 and 24 hours post-intervention
Plasma oxidised low density lipoprotein (oxLDL)
To determine the effects of hyperoxia on oxidative stress
Time frame: 6 and 24 hours post-intervention
Plasma 4-hydroxy-2-nonenal (4-HNE)
To determine the effects of hyperoxia on oxidative stress
Time frame: 6 and 24 hours post-intervention
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2022 (actual). Primary completion is estimated for Dec 2024, 24 months after the start.
Of 51 non-industry interventional studies with no phase under Acute Lung Injury, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 24 months is above that.
Counting every sponsor, half of 52 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Oxygen
Belfast Health and Social Care Trust