Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

Masimo

Status

Completed

Conditions

Healthy

Treatments

Device: INVSENSOR00069

Study type

Interventional

Funder types

Industry

Identifiers

NCT06120777

CIP-1086

Details and patient eligibility

About

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

Enrollment

89 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.