Nellcor™ Abbreviated Sensor Additional Data Collection

NCT ID: NCT07201961

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-24
• Study Completion Date: 2026-01-31

Brief 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.

Detailed Description

The purpose of this study is to collect data on the Nellcor™ Pulse Oximetry device when paired with a variety of Nellcor™ Market Released sensors under invasive, controlled desaturation conditions, to verify Pulse Rate and SpO2 accuracy in a diverse participant population over a specified saturation range.

Conditions

Oxygen Saturation Measurement

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Volunteers

All subjects who meet the inclusion criteria and none of the exclusion criteria will be enrolled into the test group and will participate in data collection with use of the Nellcor™ Pulse Oximetry device with each of the market-released Nellcor™ Pulse Oximetry test sensors.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Male or female participants ≥ 18 years of age, and < 51 years of age.

2. Participant is willing and able to comply with study procedures and duration.

3. Participant is willing to sign an ICF.

4. Participant weighs > 40kg (88.2 lb).

5. Participant is a non-smoker or has not smoked within 36 hours prior to the study.

6. Cleared same day health assessment form and health screening

7. Successful perfusion index ulnar/ulnar+radial ratio test (Assessed via the Allen's Test) showing adequate collateral blood flow.

Exclusion Criteria

1. Participant is considered as being morbidly obese (defined as BMI >39.5).

2. 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)

3. 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.

4. Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure

5. tHb < 10 g/dl as assessed by CO-Oximetry during the procedure

6. MetHb ≥ 2% as assessed by CO-Oximetry during the procedure

7. Participants with known respiratory conditions such as:

1. uncontrolled / severe asthma

2. flu or influenza type infection

3. pneumonia / bronchitis

4. shortness of breath / respiratory distress

5. unresolved respiratory or lung surgery

6. emphysema, COPD, lung disease

7. recent COVID (last 2 months)

8. Participants with known heart or cardiovascular conditions such as:

1. Uncontrolled hypertension (systolic pressure >140mmHg, or diastolic pressure >90mmHg on 3 consecutive readings day of screening)

2. previous cardiovascular surgery

3. chest pain (angina)

4. heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)

5. previous heart attack

6. blocked artery

7. unexplained shortness of breath

8. congestive heart failure (CHF)

9. history of stroke and/or transient ischemic attack

10. carotid artery disease

11. myocardial ischemia

12. myocardial infarction

13. cardiomyopathy

14. implantable active medical device such as pacemaker or automatic defibrillator

9. Self-reported health conditions as identified in the Health Assessment Form:

1. Diabetes

2. uncontrolled thyroid disease

3. kidney disease / chronic renal impairment

4. history of seizures (except childhood febrile seizures)

5. epilepsy

6. history of unexplained syncope

7. recent history of frequent migraine headaches (within the last 2 months)

8. recent symptomatic head injury (within the last 2 months)

9. cancer requiring chemotherapy, radiation, or current treatment

10. participants with known clotting disorders

11. history of bleeding disorders or personal history of prolonged bleeding from injury

12. history of blood clots

13. hemophilia

14. sickle cell trait or disease

15. current use of blood thinner: prescription or daily use of aspirin

16. participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors

17. participants with severe allergy to iodine (only applicable if iodine is used)

18. participants with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin

19. arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)

20. history of clinically significant complications from previous arterial cannulation

21. unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits

22. other known health condition, upon disclosure in Health Assessment form

10. Failure of the Allen's Test.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medtronic Clinical Physiology Lab

Denver, Colorado, United States

Countries

United States

Other Identifiers

MDT25017NQABAD

Identifier Type: -

Identifier Source: org_study_id