Hyperoxia induced inflammation and injury - human in vivo study

• Research type

  Research Study

• Full title

  Effects of hyperoxia on pulmonary inflammation and organ injury in a human in vivo model

• IRAS ID

  250826

• Contact name

  Danny McAuley

• Contact email

  d.f.mcauley@qub.ac.uk

• Sponsor organisation

  Belfast Health and Social Care Trust

• Eudract number

  2019-003635-28

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT00000000

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Intensive care treatment saves lives, but the various supportive therapies have side effects if used excessively. One of the common therapies used to support failing lungs is oxygen. Level of oxygen use in intensive care and in other medical specialities is still uncontrolled. There is evidence of harm from oxygen in patients with heart attack, stroke and cardiac arrest. The exact mechanisms through which the harmful effects are initiated is still uncertain.
  Healthy volunteer trial, as proposed here, provides the opportunity to investigate and understand the mechanisms driving oxygen related injury.
  The main trial has two parts:
  In part A, there is an initial pilot study where three healthy human volunteers will be administered supplemental oxygen for three hours which has been shown to produce safe reversible changes in large airways in previous studies. If shown to be safe, oxygen will be administered for up to six hours to healthy volunteers. This study will give us information on the effects of oxygen on lung inflammation and injury.

  In part B, healthy volunteers will inhale a small (50 micro grams) of an irritant called lipopolysaccharide followed by oxygen administration for up to six hours. This study will give us information on whether oxygen could worsen the effects of lipopolysaccharide.

  The level inflammation and injury will be studied by measuring markers in the blood and from fluid from the lung compartment. We will use a routine clinical technique that is a camera test to obtain fluid from a lung segment. Blood will be collected using routine technique.

  Our results will be applicable to not only patients in critical care but also to other patient groups such as during surgery, heart attack and after cardiac arrest.

• REC name

  HSC REC A

• REC reference

  19/NI/0181

• Date of REC Opinion

  2 Dec 2019

• REC opinion

  Further Information Favourable Opinion