N/A
N=101
Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT06334055 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073 — 1.38 Millimeters of mercury (mmHg)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Masimo INVSENSOR00073 (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073 |
1.38 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06334055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.