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Validation of the Aktiia SA PulseWatch OBPM Device at the Wrist Against Invasive Blood Pressure Measurements (OBPM_ICU2018)

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ClinicalTrials.gov Identifier: NCT03837769
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Aktiia SA
Information provided by (Responsible Party):
Hopital Neuchatelois

Brief Summary:
Single-centre intervention study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against invasive blood pressure measurements with arterial line.

Condition or disease Intervention/treatment Phase
Blood Pressure Device: Aktiia OBPM PulseWatch wrist device Not Applicable

Detailed Description:

Aktiia SA PulseWatch is an investigational device for the optical measurement of blood pressure that uses only optical sensors at the wrist. HNE is interested in exploring the potential of the device and technology (OBPM), and aims at benchmarking its performances against gold standard measurements of blood pressure.

The goal of this study is thus to assess whether i) PulseWatch allows to capture blood pressure variations, and ii) the measured blood pressure values remain stable in time.

The proposed study plans to include patients that are already scheduled for arterial catheterization at HNE. For these patients, the study will only require the placement of the safe optical device on the wrist to non-invasively record hemodynamic fluctuations. Therefore, no additional risk for the patient is to be foreseen.

By demonstrating that the Aktiia SA OBPM technology is reliable, HNE aims to make one step further in improving blood pressure monitoring in general, and in particular in advancing the deployment of technologies that have the potential to be used in the ambulatory setting. The diagnosis and treatment of hypertension are expected to largely benefit from these advancements.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Single-center Intervention Study to Validate the Performance of the Aktiia SA PulseWatch Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Invasive Blood Pressure Measurements With Arterial Line
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Arm Intervention/treatment
Experimental: Aktiia SA PulseWatch
Aktiia OBPM PulseWatch wrist device
Device: Aktiia OBPM PulseWatch wrist device
The optical signals at the wrist are recorded non-invasively. The BP measurements are further determined from these optical signals and are compared to the reference BP readings.




Primary Outcome Measures :
  1. Cuffless Blood Pressure performance [ Time Frame: 4 Months ]
    The evaluation of the accuracy (mean error and standard deviation of the error) of the non-invasive BP measurements at wrist with the PulseWatch against the reference gold-standard invasive blood pressure obtained by arterial line with respect to ISO 81060-2 (14) for two aspects: i) capturing the variations of the BP in short time and ii) maintaining the accurate stable measurements over extended periods of time.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age ≥ 18 years
  • No significant non-invasive systolic blood pressure difference between left arm and right arm (difference <20mmHg in systolic arterial pressure)
  • Patient requires continuous monitoring of diastolic and systolic blood pressure continuously via a radial arterial line;
  • Patient information and informed consent is obtained following the procedures described in CIP

Exclusion criteria:

  • Arrythmias: tachycardia (resting heart rate > 120/min) at time of study inclusion
  • Atrial fibrillation
  • Psychomotor agitation
  • Significant bruises or trauma on forearm
  • Intravenous canula around the wrist with impossibility to place the device (Aktiia OBPM PulseWatch) around the wrist

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837769


Contacts
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Contact: Cyril Pellaton, MD +4132 713 35 97 hne.secretariatpellaton@h-ne.ch

Locations
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Switzerland
Hôpital neuchâtelois - Pourtalès Recruiting
Neuchâtel, Switzerland, 2000
Contact: Cyril Pellaton, MD         
Sponsors and Collaborators
Hopital Neuchatelois
Aktiia SA

Additional Information:
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Responsible Party: Hopital Neuchatelois
ClinicalTrials.gov Identifier: NCT03837769     History of Changes
Other Study ID Numbers: OBPM_ICU2018
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hopital Neuchatelois:
Blood Pressure
OBPM
Cuffless