Healthy
Conditions
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.
Interventions
DEVICEMasimo INVSENSOR00073
Noninvasive blood pressure monitor
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073 | 1-5 hours. | Accuracy and precision of mean arterial pressure (MAP) measured by Masimo INVSENSOR00073 in comparison to radial arterial line. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Subject All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor.
Masimo INVSENSOR00073: Noninvasive blood pressure monitor | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Disqualified | 72 |
Baseline characteristics
| Characteristic | Test Subject |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 10 / 101 |
| serious Total, serious adverse events | 0 / 101 |
Outcome results
Primary
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.
Time frame: 1-5 hours.
Population: 9 subjects not analyzed due to incorrect software version
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Masimo INVSENSOR00073 | Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073 | 1.38 Millimeters of mercury (mmHg) | Standard Deviation 4.98 |