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

Intraoperative Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03795831
• Other study ID #: 2017-14
• Status: Recruiting
• Start date: March 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2019
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: D.P. Veelo, Dr
• Phone: 0031205662533
• Email: d.p.veelo[@]amc.uva.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients whose arterial blood pressure is measured invasively with technology that allows for the storage of the intra-arterial waveform with sufficient quality and resolution (Flotrac).

• Patients older than 18, for elective general surgery.

Exclusion Criteria:

• Patient conditions that are expected to potentially and significantly affect the transfer of pressure between radial artery and the finger, e.g. due to recent finger fractures

Related Conditions & MeSH terms

• Hypotension
• Intraoperative Hypotension

Intervention

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

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Edwards Lifesciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	validation systole, diastole, mean ABP and pulse pressure	accuracy and precision of invasive blood pressure curve vs non-invasive blood pressure curves(ipsilateral and contralateral)	within 1 hour
Primary	implementation of software alterations to improve systole, diastole, mean ABP accuracy and pulse pressure	Comparison of the non-invasive blood pressure curve after software alterations to the reference and invasive arterial blood pressure curve	time during surgery