NCT03795831

Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Collecting all available data (waveforms, beat to beat data, status data) generated by a non invasive blood pressure monitor on each hand and compare this to the actual data obtained by intra arterial (radial) monitoring. This to see if the non invasive bloodpressure monitor can be validated for intraoperative use.

Detailed description

Although a blood pressure monitoring device could be evaluated by the comparing systolic, diastolic and mean arterial pressure to a reference pressure, it is the specific aim to collect all available data (waveforms, beat to beat data, status data) generated by the blood pressure monitor. After data analysis and comparison to patient's actual intra-arterial waveform, the outcome will be evaluated by Association for the Advancement of Medical Instrumentation (AAMI) standards to see if the non invasive bloodpressure monitor can be validated for intraoperative use. The study is targeted at patients already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor. This study is a substudy of a feasability protocol evaluating a new algorithm for the Clearsight system.

Conditions

• Intraoperative Hypotension

Interventions

Type	Name	Description
DEVICE	ClearSight feasibility testing	A cuff is placed on a finger of the patient. The ClearSight system uses a volume clamp technology allowing measuring of continuous blood pressure waveform. Note: There will only be observational recordings, no interventions

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2019-01-08
• Last updated: 2019-01-10

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated device study