OM2 Low Saturation Verification

NCT06661889 | Completed

• 1 other identifier: MDT23028OM2VLS
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.

Conditions

Hypoxia

Keywords

Low Saturation; Pulse Oximetry

Outcome Measures

Primary Outcomes (3)

• Verification of Saturation Accuracy

  Verification of Saturation Accuracy Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for SpO2 during low saturation conditions across the saturation range of 60-80%: SpO2 Max-A ±3% (ARMS) Max-N ±3% (ARMS) OxySoft-N ±3% (ARMS) Max-Fast ±3%(ARMS)

  2.5 hours

• Acceptance criteria for SpO2 accuracy across the saturation range of 70-100%:

  Verification of Saturation Accuracy Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for SpO2 during saturation conditions across the saturation range of 70-100%: SpO2 Max-A ±2% (ARMS) Max-N ±2% (ARMS) OxySoft-N ±2% (ARMS) Max-Fast ±2%(ARMS)

  2.5 hours

• Acceptance criteria for pulse rate accuracy within 20-250 BPM

  Pulse rate accuracy Max-A \<=3 BPM (ARMS) Max-N \<=3 BPM (ARMS) OxySoft-N \<=3 BPM (ARMS) Max-Fast \<=3 BPM(ARMS)

  2.5 hours

Study Arms (1)

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Male or Female volunteers age 18 to 39 years, weighing greater than 40kgs. Volunteers must be non-smokers or not smoked within 2 days prior to the study. Cleared a same day health assessment form and health screen to ensure none of the exclusion criteria was met. With a successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow.

You may qualify if:

• Healthy volunteers 18 to ≤39 years
• Subject is willing and able to comply with study procedures and duration
• Subject is willing to sign an informed consent
• Subject weighs \>40kg
• Subject is a non-smoker or has not smoked within 2 days prior to the study
• Cleared same day health assessment form and health screening

You may not qualify if:

• Subject 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 subjects to participate if the condition is noted and would not affect the sites utilized)
• Subjects 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 known concurrent, active 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)
• Subjects with known heart or cardiovascular conditions such as:
• hypertension: systolic \>140mmHg, or Diastolic \>90mmHg on 3 consecutive readings
• have had cardiovascular surgery
• chest pain (angina)

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 Officials

• Randall M Clark

  Medtronic Clinical Physiology Laboratory

  PRINCIPAL INVESTIGATOR

• David Macleod

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: November 18, 2024
• Primary Completion: February 27, 2025
• Study Completion: May 27, 2025
• Last Updated: July 28, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)