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OpenTrials
Completed

NCT Number: NCT06334055

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Corporation

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Masimo INVSENSOR00073

Device

Noninvasive blood pressure monitor

Primary outcomes

  1. Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073

    Time frame: 1-5 hours.

    Accuracy and precision of mean arterial pressure (MAP) measured by Masimo INVSENSOR00073 in comparison to radial arterial line.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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