Nellcor™ Abbreviated Sensor Additional Data Collection

NCT07201961 | Completed

• 1 other identifier: MDT25017NQABAD
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygen Saturation Measurement

Keywords

Hypoxia; Pulse Oximetry; Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Evaluation of pulse rate accuracy

  Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the pulse rate measurement from the Nellcor Pulse Oximetry device to the heart rate measurements as obtained by ECG.

  2 - 3 hours

• Evaluation of saturation accuracy

  Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the noninvasive oxygen saturation measurement (SpO2) to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample.

  2-3 Months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy participants ≥ 18 and \< 51 years of age, with varying skin tones and diversity across ethnicity, race, gender, and sex assigned at birth.

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:

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Medtronic Clinical Physiology Lab

Denver, Colorado, 80218, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: October 1, 2025
• Study Start: July 24, 2025
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: March 12, 2026

Record last verified: 2025-07

Locations

US (1)