Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

• Sponsor: Masimo Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06120777
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 2.5
• Patients Per Site Per Month: 7.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: INVSENSOR00069	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Clinical Validation for SpO2 Function of Masimo INVSENSOR00069
• Actual Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Jan 15, 2024
• Anticipated Study Completion Date: Jan 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Subject All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069.	Device: INVSENSOR00069; Noninvasive pulse oximeter

Outcome Measures

Primary Outcome Measures

1. Peripheral oxygen saturation (SpO2) accuracy of INVSENSOR00069 [1-3 hours]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masimo Corporation	Irvine	California	United States	92618

Sponsors and Collaborators

• Masimo Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT06120777
• Other Study ID Numbers: CIP-1086
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 7, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Nov 7, 2023