Phase 4
N=33
Neuroimaging During Pure Oxygen Breathing
Hyperoxia · Hypoxia, Brain · Neurobehavioral Manifestations
Bottom Line
View on ClinicalTrials.gov: NCT03268590 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Cerebral Blood Flow — 48.54; 36.17 ml/min/100g tissue — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxygen (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cerebral Blood Flow |
48.54; 36.17 | <0.05 sig |
| SECONDARY Cortical Network Activity |
6.15; 6.75 | <0.05 sig |
| SECONDARY Cognitive Performance |
97.91; 221.70 | <0.05 sig |
Summary
The investigators will conduct a non-randomized clinical trial to examine the effect of pure oxygen breathing on the brain. The study will compare cerebral blood flow, cortical electrical activity, and cognitive performance in 32 persons during room air (21% oxygen) breathing and pure oxygen (100% oxygen) breathing. Subjects will be used as their own controls. The investigators aim to:
1. Determine whether breathing 100% oxygen changes blood flow through the brain. The investigators will learn whether brain blood flow is increased, decreased or stays the same.
2. Determine if changes that might occur in brain blood flow are also accompanied by changes in the brain's electrical activity (EEG).
3. Learn whether changes in the speed at which the brain processes information (cognitive function) accompany changes in brain blood flow and electrical activity that may be seen.
Eligibility Criteria
Inclusion Criteria
- Persons recruited from currently approved Human Subject Panel for high altitude studies at Wright Patterson Air Force Base, Dayton, OH. Volunteers will have documentation of past exposure to hypobaric conditions, either from past high-altitude flight, as hypobaric chamber personnel, or as participants in previous/current high altitude studies. Persons without past exposure to hypobaric conditions were also eligible to participate.
- Height 152.5-195.5 cm, weight 40-135 kg.
Exclusion Criteria
- Persons who have contraindications to MRI such as cardiac pacemakers, intracranial aneurysm clips, metallic implants or external clips within 10 mm of the head; implanted metallic devices such as pumps or previously implanted neurostimulation devices; cochlear implants, defibrillators, pacing wires, body piercings that cannot be removed, metal filings such as shrapnel, tattoos on the head and neck, or medical conditions contraindicated for MRI safety.
- History of claustrophobia
Data sourced from ClinicalTrials.gov (NCT03268590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.