HypotensionNCT03629535
Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband
A study testing Non-invasive non-oscillometric blood pressure wristband device and Invasive intra-arterial blood pressure monitors. in people with Hypotension and Hypertension, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypotension, Hypertension
- What is being tested?
- Non-invasive non-oscillometric blood pressure wristband device and Invasive intra-arterial blood pressure monitors.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 10 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the Surgical Intensive Care Unit who are already fitted with an invasive Arterial Line (A- Line) are eligible for the trial, and no volunteers candidates for an A Line are requested.
Who cannot join
- Within the candidate group of individuals whose procedure in the hospital requires an A-Line, the wristband may not, for various reasons, produce a clean signal. This is immediately determined after wearing the band (and may be related to the size of the wrist of the subject, among other things). Such candidates will be excluded from admission to the study.
- All data from a subject shall be excluded if the invasive reference systolic blood range is greater than 20 mmHg (2, 67 kPa) or if the invasive reference diastolic range is more than 12 mmHg (1, 6 kPa) in any single determination.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Conditions
- Hypotension, Hypertension
- Being tested
- Non-invasive non-oscillometric blood pressure wristband device, Invasive intra-arterial blood pressure monitors.
- Medical subject headings
- Hypotension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive non-oscillometric blood pressure wristband deviceDevice
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.Device
Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control
| Study group | Role | What they receive |
|---|---|---|
| Patients in SICU | Experimental | Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects. Receives: Device: Non-invasive non-oscillometric blood pressure wristband device; Device: Invasive intra-arterial blood pressure monitors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during intervention for 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Apr 2019
- Primary completion10 Sep 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Greta Piper, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629535
- Sponsor's protocol ID
- 17-00884
- Status last verified
- Jan 2021
- First submitted
- 9 Aug 2018
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband
- ClinicalTrials.gov ID
- NCT03629535
- Acronym / sponsor ID
- 17-00884
- Conditions
- Hypotension, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in SICU | Experimental | Device: Non-invasive non-oscillometric blood pressure wristband device, Device: Invasive intra-arterial blood pressure monitors.Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the Surgical Intensive Care Unit who are already fitted with an invasive Arterial Line (A- Line) are eligible for the trial, and no volunteers candidates for an A Line are requested.
Key exclusion criteria (2 listed)
- Within the candidate group of individuals whose procedure in the hospital requires an A-Line, the wristband may not, for various reasons, produce a clean signal. This is immediately determined after wearing the band (and may be related to the size of the wrist of the subject, among other things). Such candidates will be excluded from admission to the study.
- All data from a subject shall be excluded if the invasive reference systolic blood range is greater than 20 mmHg (2, 67 kPa) or if the invasive reference diastolic range is more than 12 mmHg (1, 6 kPa) in any single determination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive non-oscillometric blood pressure wristband deviceThe 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. | Device | Patients in SICU |
| 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 | Device | Patients in SICU |
Primary outcome
Average Error in Blood Pressure Readings
Time frame: during intervention for 30 minutes
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greta Piper principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive non-oscillometric blood pressure wristband device and Invasive intra-arterial blood pressure monitors. in people with Hypotension and Hypertension, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Error in Blood Pressure Readings (time frame: during intervention for 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.