Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
38 participants
OBSERVATIONAL
2025-09-29
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Volunteers
Healthy, non-smoking volunteers ages ≥18 to \<47 years who meet inclusion criteria
Observational
The study objectives require placement of a jugular venous bulb catheter and radial arterial line placement with ultrasound guidance. Two INVOS™ sensors (PMSENS71-A) will be placed bilaterally on the subject's forehead and two on the calf. The INVOS™ device will be evaluated for a targeted range of 70-100% SpO2 levels. Hypoxic mixtures of gas are delivered, and data are collected at approximately (\~) 5-minute intervals during steady periods of increasing and decreasing oxygen concentration.
Interventions
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Observational
The study objectives require placement of a jugular venous bulb catheter and radial arterial line placement with ultrasound guidance. Two INVOS™ sensors (PMSENS71-A) will be placed bilaterally on the subject's forehead and two on the calf. The INVOS™ device will be evaluated for a targeted range of 70-100% SpO2 levels. Hypoxic mixtures of gas are delivered, and data are collected at approximately (\~) 5-minute intervals during steady periods of increasing and decreasing oxygen concentration.
Eligibility Criteria
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Inclusion Criteria
* Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant
* Subject is a non-smoker or has not smoked within 2 days prior to the study
* Minimum weight 40kg
* BMI within range 18.0-- 35.0
* Reference tissue hemoglobin oxygen saturation over the range 50% to 85%
Exclusion Criteria
* Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self-reported\]
* Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\]
* Subjects taking certain medication(s) beyond birth control may be excluded from participating at the PI discretion \[self-reported\]
* Subject participation will be at the PI's discretion if they are currently participating in, or if they have recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study \[self-reported\]
* Negative Allen's test for radial and ulnar patency
* Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\]
* Individuals of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study and is unwilling to use effective birth control between the time of screening and study procedure, or is breastfeeding.
* Has anemia \[lab values specific for gender\]
* Has a history of sickle cell trait or thalassemia \[self-reported\]
* Has an abnormal hemoglobin electrophoresis test \[lab measurement\]
* Has a positive urine cotinine test or urine drug screen or oral ethanol test \[Point of Care (POC) testing\]
* Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\]
* Has a clinically significant abnormal ECG \[assessment by PI or delegate\]
* Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\]
* Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co-oximetry\]
* Has tHb \< 10 g/dl as assessed by co-oximetry during the procedure
18 Years
46 Years
ALL
Yes
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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David MacLeod, MDDS
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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David MacLeod, M.B.B.S.
Role: primary
Other Identifiers
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MDT24046IN4WVL
Identifier Type: -
Identifier Source: org_study_id