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The purpose of this study is to compare measurements of blood pressure (BP) and fluid responsiveness between the Philips AMC and invasive radial arterial line in surgical patients.
Primary Objective:
• To evaluate equivalence of BP measurements (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP], and Mean Arterial Pressure [MAP]) derived from the Philips AMC to the radial arterial line as ground truth.
Secondary Objectives:
Hypothesis: Blood pressure measurements derived from the Philips AMC are equivalent to the radial arterial line and superior to the oscillometric non-invasive blood pressure (NIBP) cuff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Philips AMC Cuff | This is a non-randomized, single arm, self-controlled observational study. The Philips AMC cuff will be tested on all enrolled participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philips Advanced Monitoring Cuff (i.e. AMC) | Device | Investigational, non-invasive upper arm cuff |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoints | The comparison of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) between the Philips AMC and radial arterial line. | Approximately 8 months accrual and follow-up evaluation period. |
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Inclusion Criteria:
The following stratification criteria must be met across the study sites and hence targeted enrollment may be required:
Age of every patient 18+; at least 30% > 65 years, 30% ≤ 65 years
At least 30% male, 30% female
Minimum number of subjects needed to test each size cuff (per ISO81060-2:2018/AMD2:2024, based on limb circumference range):
At least 40% of the subjects within each cuff size shall have a limb circumference that lies within the upper half of the specified range of use of the cuff
At least 40% of the subjects within each cuff size shall have a limb circumference within the lower half of the specified range of use of the cuff
At least 10% SBP measurements ≤ 100 mmHg
At least 10% SBP measurements ≥ 160 mmHg
At least 10% DBP measurements ≤ 70 mmHg
At least 10% DBP measurements ≥ 85 mmHg
Exclusion Criteria:
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Up to 205 non-cardiac surgical or Intensive Care Unit (ICU) patients being monitored with a radial arterial line will be enrolled over approximately 8 months accrual and follow-up evaluation period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lea Egger | Contact | +49 1722314318 | lea.egger@philips.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States | |
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| Duke University Health System |
| Recruiting |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Wake Forest Baptist Medical Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| LMU Klinikum , Campus Großhadern | Recruiting | München | Bavaria | 81377 | Germany |