CompletedNot Applicable

Nellcor™ Abbreviated Sensor Additional Data Collection

United States55 participantsStarted 2025-07-24

Plain-language summary

To collect data on a variety of market approved Nellcor™ pulse oximetry sensors with the Nellcor™ Pulse Oximetry device to support the market approval.

Who can participate

Age range18 Years – 51 Years

SexALL

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Inclusion criteria

✓. Male or female participants ≥ 18 years of age, and \< 51 years of age.
✓. Participant is willing and able to comply with study procedures and duration.
✓. Participant is willing to sign an ICF.
✓. Participant weighs \> 40kg (88.2 lb).
✓. Participant is a non-smoker or has not smoked within 36 hours prior to the study.
✓. Cleared same day health assessment form and health screening
✓. Successful perfusion index ulnar/ulnar+radial ratio test (Assessed via the Allen's Test) showing adequate collateral blood flow.

Exclusion criteria

✕. Participant is considered as being morbidly obese (defined as BMI \>39.5).
✕. Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized)
✕. Participants 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.
✕. Subjects with COHb levels \>3% as assessed by CO-Oximetry during the procedure
✕. tHb \< 10 g/dl as assessed by CO-Oximetry during the procedure
✕. MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
✕. Participants with known respiratory conditions such as:
✕. uncontrolled / severe asthma

What they're measuring

Evaluation of pulse rate accuracy

Timeframe: 2 - 3 hours

Evaluation of saturation accuracy

Timeframe: 2-3 Months

Trial details

NCT IDNCT07201961

SponsorMedtronic - MITG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-08-26

View on ClinicalTrials.gov More Oxygen Saturation Measurement trials