Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

Healthy Clinical Trial

Official title:

Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06120777
• Other study ID #: CIP-1086
• Status: Completed
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 12, 2023

Study information

• Verified date: November 2023
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• INVSENSOR00069
Noninvasive pulse oximeter

Locations

Country	Name	City	State
United States	Masimo Corporation	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral oxygen saturation (SpO2) accuracy of INVSENSOR00069	Accuracy of INVSENSOR00069 will be determined by calculating the root mean square (ARMS) value through comparison of the peripheral oxygen saturation measurement (SpO2) of INVSENSOR00069 against contemporaneous measurements from arterial blood gas (ABG) analysis (SaO2).	1-3 hours