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

NCT03795831 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-01-10

No results posted yet for this study

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.

Conditions

  • Intraoperative Hypotension

Interventions

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

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • D.P. Veelo, Dr · inverstigator

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2019-12-30
Completion
2019-12-30
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03795831 on ClinicalTrials.gov