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OpenTrials
Completed

NCT Number: NCT02479724

A-line/CareTaker Comparison Study in ICU Patients

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

About this study

The object of the work presented here was to validate a new approach to tracking blood pressure that is based on the pulse analysis of the peripheral arterial pressure pulse. The approach, referred to as the Pulse Decomposition Analysis (PDA) model, goes beyond traditional pulse analysis by invoking a physical model that comprehensively links the components of the peripheral pressure pulse envelope with two reflection sites in the central arteries.

In these experiments, approved by the University of Virginia Institutional Review Board, the arterial blood pressures of patients (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) were monitored using radial intra-arterial catheters, while the CareTaker system collected pulse line shapes at the lower phalange of the thumb of the ipsilateral hand.

Systolic and diastolic blood pressures continuously collected from the arterial catheter and CT were compared. Pearson correlation coefficients were calculated between arterial catheter and CT blood pressure measurements and a Bland-Altman analysis was created. Results were within the limits established for the validation of automatic arterial pressure monitoring (AAMI/ANSI/ISO 81060-1:2013).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • failure to meet all of the inclusion criteria

Treatment and study plan

continuous non-invasive blood pressure monitor

Device

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

Primary outcomes

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

    Time frame: 40 minutes

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

Sponsors and collaborators

Lead sponsor

Empirical Technologies Corporation

Industry

Collaborators

  • University of Virginia

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jun 24, 2015
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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