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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03837769
Recruitment Status : Completed
First Posted : February 12, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
Aktiia SA
Information provided by (Responsible Party):
Hopital Neuchatelois

Tracking Information
First Submitted Date  ICMJE February 6, 2019
First Posted Date  ICMJE February 12, 2019
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE February 12, 2019
Actual Primary Completion Date May 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of the Aktiia SA PulseWatch OBPM Device at the Wrist Against Invasive Blood Pressure Measurements
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Blood Pressure
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Aktiia SA PulseWatch
Aktiia OBPM PulseWatch wrist device
Intervention: Device: Aktiia OBPM PulseWatch wrist device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2019)
31
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2019)
30
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date May 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03837769
Other Study ID Numbers  ICMJE OBPM_ICU2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hopital Neuchatelois
Study Sponsor  ICMJE Hopital Neuchatelois
Collaborators  ICMJE Aktiia SA
Investigators  ICMJE Not Provided
PRS Account Hopital Neuchatelois
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP