Status:
COMPLETED
Validation of the Aktiia SA PulseWatch OBPM Device at the Wrist Against Invasive Blood Pressure Measurements
Lead Sponsor:
Hopital Neuchatelois
Collaborating Sponsors:
Aktiia SA
Conditions:
Blood Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
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 li...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03837769
Start Date
February 12 2019
End Date
May 31 2019
Last Update
June 3 2019
Active Locations (1)
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1
Hôpital neuchâtelois - Pourtalès
Neuchâtel, Switzerland, 2000