Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073

The aim of the study is to validate the Mean Arterial Pressure (MAP) parameter of Masimo INVSENSOR00073 against the gold standard blood pressure measurements from the arterial line while subject undergo a blood pressure variation procedure.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Masimo INVSENSOR00073

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Masimo Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Influenced by study design:

• Subject is 18 to 40 years of age.
• Subject weighs a minimum of 110 lbs.
• Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
• Baseline blood pressure:
• Systolic blood pressure ≤ 135 mmHg and ≥ 100 mmHg.
• Diastolic blood pressure ≤ 95 mmHg and ≥ 55 mmHg.
• Valid systolic blood pressure (SBP) auscultatory measurements for lateral difference is ≤ 15 mmHg.
• Valid diastolic blood pressure (DBP) auscultatory measurements for lateral difference is ≤ 10 mmHg.
• Hemoglobin value ≥ 11 g/dL.
• 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:

• Subject is pregnant or breastfeeding.
• Subject is experiencing dysrhythmia or arrhythmia.

Influenced by study design/environment:

• Subject is concurrently participating in another research study.
• Subjects not suitable for the investigation at the discretion of the clinical team including but not limited to the items below.
• Subjects who do not pass the health assessment for safe participation in the study procedures.
• Inability to insert or difficulty with 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Subject; All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor.	Device: Masimo INVSENSOR00073; Noninvasive blood pressure monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073	Accuracy and precision of mean arterial pressure (MAP) measured by Masimo INVSENSOR00073 in comparison to radial arterial line.	1-5 hours.

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Actual): November 8, 2024
• Study Completion (Actual): November 8, 2024

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CIP-1091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No