Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

NCT06120777 | Completed Results FDA Device

• 1 other identifier: CIP-1086
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the accuracy of INVSENSOR00069's peripheral oxygen saturation (SpO2) against contemporaneous measurement from arterial blood gas (ABG) analysis.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• SpO2 Accuracy of Masimo INVSENSOR00069

  The SpO2 accuracy of Masimo INVSENSOR00069 was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SaO2\_i )\^2 ))/n.

  1-3 hours

Study Arms (1)

Test Subject

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069.

Device: INVSENSOR00069

Interventions

INVSENSOR00069 DEVICE

Noninvasive pulse oximeter

Test Subject

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Influenced by study design:
• Subject is 18 to 50 years of age.
• Subject weighs a minimum of 110 lbs.
• Hemoglobin value ≥ 11 g/dL.
• Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
• Systolic blood pressure ≤ 140 mmHg and ≥ 90 mmHg and diastolic blood pressure ≤ 90 mmHg and ≥ 50 mmHg. If systolic blood pressure is lower than 100 mmHg and/or diastolic blood pressure is lower than 60 mmHg, subject passes an orthostatic blood pressure test.
• CO value ≤ 3.0% FCOHb.
• Subject is comfortable to read and communicate in English\*. \*This is to ensure the subject can provide informed consent (as study materials are currently available in English only) and can comply with study procedures.

You may not qualify if:

• Influenced by device warning labels:
• Subjects with a skin condition affecting the digits, where the sensor is applied, which would interfere with the path of light (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
• Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them.
• Subject has hemoglobinopathies or synthesis disorders (e.g., thalassemia, sickle cell disease).
• Subject has a peripheral vascular or vasospastic disease (e.g., Raynaud's disease).
• Influenced by study design/environment:
• Subjects who do not pass the health assessment for safe participation in the study procedures.
• Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Ahmed Alghazi
• Organization: Masimo Corporation

studies@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-11

Locations

US (1)