Non-Invasive Positive Pressure Ventilation on Oxygen Saturations without Supplemental Oxygen at Altitude
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-003189
About this study
The purpose of this study is to assess changes in cognitive function and physiological signs that may be affected at General Aviation altitudes considered safe by the Federal Aviation Administration; and whether these affects can be mitigated by through the use of a simple non-invasive positive pressure device.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Healthy male or female participants.
- Between the ages of 18 and 89.
- Must have had experience as a pilot or passenger in an unpressurized general aviation aircraft at altitudes above 8,000 feet and have not experienced any serious adverse effects from this experience (such as serious vertigo, loss of consciousness, any cardiac or respiratory dysfunction, or any other illness requiring medical treatment).
- Participants need to be able to complete cognitive tests.
- Must be fluent in English.
Exclusion Criteria:
- Patients < 18 years of age or > 89 years of age.
- Pregnant women.
- Unable to read and speak English.
- History of Cardiac disease, Pulmonary disease, Cerebrovascular disease, Neurological disease, Vertigo, or Syncope.
- Any documented incidences of Serious Adverse effects from General Aviation.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Bruce Johnson, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available