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

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT06334055

Run by

Masimo Corporation

People needed

101

Starts

2024-03-04

Expected to finish

2024-11-08

Last updated by the study team

2025-07-10

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Masimo Corporation — Irvine, California, United States

Full record on ClinicalTrials.gov

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