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The primary objective of the present investigation is to determine the accuracy of a non-invasive non-oscillometric blood pressure wristband device when compared to invasive intra-arterial blood pressure monitors. In an intensive care unit patients who already have an intra-arterial blood pressure monitor in place, this wristband device will be applied and blood pressure readings compared for approximately 15 minutes. Blood pressure readings will be gathered and compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in SICU | Experimental | Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive non-oscillometric blood pressure wristband device | Device | The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Error in Blood Pressure Readings | If the value obtained from the LiveMetric determination lied within the range of the reference BP, an error of 0 mm Hg (0kPa) was assigned to this determination. If the value obtained from the LiveMetric determination lies outside the range of the reference BP, the value of the determination from the adjacent limit of the range of the variation of BP was subtracted. That difference represents the error for this determination. The arithmetic mean of the error is calculated and its experimental standard deviation from the errors of each recording for each BP value (Systolic & Diastolic) and determination for each patient. | during intervention for 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greta Piper | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Data will be available upon reasonable request. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients in SICU | Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects. Non-invasive non-oscillometric blood pressure wristband device: The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet. Invasive intra-arterial blood pressure monitors.: Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients in SICU | Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects. Non-invasive non-oscillometric blood pressure wristband device: The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet. Invasive intra-arterial blood pressure monitors.: Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Error in Blood Pressure Readings | If the value obtained from the LiveMetric determination lied within the range of the reference BP, an error of 0 mm Hg (0kPa) was assigned to this determination. If the value obtained from the LiveMetric determination lies outside the range of the reference BP, the value of the determination from the adjacent limit of the range of the variation of BP was subtracted. That difference represents the error for this determination. The arithmetic mean of the error is calculated and its experimental standard deviation from the errors of each recording for each BP value (Systolic & Diastolic) and determination for each patient. | Posted | Mean | Standard Deviation | mmHg | during intervention for 30 minutes |
|
during intervention for 30 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients in SICU | Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects. Non-invasive non-oscillometric blood pressure wristband device: The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet. Invasive intra-arterial blood pressure monitors.: Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Greta Piper, MD | NYU Langone Health | 212-263-4778 | Greta.Piper@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2019 | Jan 11, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Invasive intra-arterial blood pressure monitors. | Device | Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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