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

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: Masimo INVSENSOR00073

Study type: Interventional

Funder types: Industry

Identifiers

NCT06334055

CIP-1091

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

Test Subject

Experimental group

Description:

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor.

Treatment:

Device: Masimo INVSENSOR00073