NCT02479724

Brief Summary

Comparison of Blood Pressures obtained with the Pulse Decomposition Algorithm and Intra-Arterial Catheters in ICU Patients

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

11 months

First QC Date

June 22, 2015

Last Update Submit

June 22, 2015

Conditions

Blood Pressure

Keywords

continuous, non-invasive

Outcome Measures

Primary Outcomes (1)

  • Performance comparison according to AAMI/ANSI/ISO 81060-1:2013

    Correlation and standard deviation between both blood pressure measurement systems were assessed according to 81060 standards.

    40 minutes

Interventions

continuous non-invasive blood pressure monitorDEVICE

continuous blood pressure monitoring using device in parallel with Gold Standard (A-line)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

(23 m/11 f, mean age: 44.05 y, SD: 13.9 y, mean height: 173.3 cm, SD: 9.4 cm, mean weight: 95.3 kg, SD: 27.4 kg) hospitalized in University of Virginia Medical Intensive Care Units (MICUs)

You may qualify if:

  • male or female age 18 to 45
  • presence of a radial arterial catheter
  • informed consent by subject or surrogate
  • available digital pulse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Martin C. Baruch, PhD

    Empirical Technologies Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 24, 2015

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

June 24, 2015

Record last verified: 2015-06