Nellcor™ Abbreviated Sensor Additional Data Collection

Completed

Conditions studied: Oxygen Saturation Measurement

In brief

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

Key facts

Study ID

NCT07201961

Run by

Medtronic - MITG

People needed

55

Starts

2025-07-24

Expected to finish

2025-08-26

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older, up to 51. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• flu or influenza type infection
• pneumonia / bronchitis
• shortness of breath / respiratory distress
• unresolved respiratory or lung surgery
• emphysema, COPD, lung disease
• recent COVID (last 2 months)
• Participants with known heart or cardiovascular conditions such as:
• Uncontrolled hypertension (systolic pressure >140mmHg, or diastolic pressure >90mmHg on 3 consecutive readings day of screening)
• previous cardiovascular surgery
• chest pain (angina)
• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
• previous heart attack
• blocked artery
• unexplained shortness of breath
• congestive heart failure (CHF)
• history of stroke and/or transient ischemic attack
• carotid artery disease

Where it is running

• Medtronic Clinical Physiology Lab — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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