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Hypoxia at Multiple Wavelengths of Light

N

Nonin Medical

Status

Completed

Conditions

Hypoxia in Healthy Individuals

Study type

Observational

Funder types

Industry

Identifiers

NCT01957891
QATP2552

Details and patient eligibility

About

The purpose of the study is to assess the effect of progressive, incremental hypoxia at multiple wavelengths of light.

Full description

No additional information is required.

Enrollment

26 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Is between 18 and 35 years of age
  • Is American Society Anesthesiologist status 1
  • Has a BMI between 18 and 30

Exclusion criteria

  • Currently taking any medications other than birth control pills
  • Has participate in an investigational drug study within one month prior to the start of the study
  • Fails the Allen's Test to confirm patency of the colateral artery
  • Subject is female with a positive pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study termination
  • Has a positive urine continine or drug test
  • Has an reported allergy to Lidocaine
  • Has anemia or other hemoglobinopathy
  • Has a room air saturation less than 95% by pulse oximetry
  • Has an abnormal EKG
  • Has an abnormal pulmonary function test via spirometry
  • Is intolerant to a breathing mask apparatus
  • Has a COHb greater than 3%, or MetHb greater than 2%
  • Has another condition, which in the opinion of the principle investigator would not be suitable for participation in the study
  • Is unwilling or unable to provide informed consent or comply with the study procedures

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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