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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT06334055
• Lead Sponsor: Masimo Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-04
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-27
• Primary Completion: 2024-11-08
• Study Completion: 2024-11-08
• Status Verified: 2025-06
• Results First Submitted: 2025-06-23
• Results First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Results First Posted: 2025-07-10
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Masimo Corporation; 🇺🇸 Irvine, California, United States