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

NCT06334055 | Completed Results FDA Device

• 1 other identifier: CIP-1091
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Test Subject

EXPERIMENTAL

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

Device: Masimo INVSENSOR00073

Interventions

Masimo INVSENSOR00073 DEVICE

Noninvasive blood pressure monitor

Test Subject

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Ahmed Alghazi, M.B.Ch.B
• Organization: Masimo Corporation

studies@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 27, 2024
• Study Start: March 4, 2024
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: July 10, 2025
• Results First Posted: July 10, 2025

Record last verified: 2025-06

Locations

US (1)