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

NCT03837769 | Completed DMC

• 1 other identifier: OBPM_ICU2018
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

Blood Pressure; OBPM; Cuffless

Outcome Measures

Primary Outcomes (1)

• Cuffless Blood Pressure performance

  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.

  4 Months

Study Arms (1)

Aktiia SA PulseWatch

EXPERIMENTAL

Aktiia OBPM PulseWatch wrist device

Device: Aktiia OBPM PulseWatch wrist device

Interventions

Aktiia OBPM PulseWatch wrist device 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.

Aktiia SA PulseWatch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Neuchatelois: lead
• Aktiia SA: collaborator

Study Sites (1)

Hôpital neuchâtelois - Pourtalès

Neuchâtel, 2000, Switzerland

Location

Related Links

• Aktiia SA website

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 12, 2019
• Study Start: February 12, 2019
• Primary Completion: May 22, 2019
• Study Completion: May 31, 2019
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)