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A-line/CareTaker Comparison Study in ICU Patients

A-line/CareTaker Comparison Study in ICU Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02479724
Enrollment
60
Registered
2015-06-24
Start date
2012-01-31
Completion date
2013-06-30
Last updated
2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

continuous, non-invasive

Brief summary

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

Detailed description

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).

Interventions

DEVICEcontinuous non-invasive blood pressure monitor

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

Sponsors

University of Virginia
CollaboratorOTHER
Empirical Technologies Corporation
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Performance comparison according to AAMI/ANSI/ISO 81060-1:201340 minutesCorrelation and standard deviation between both blood pressure measurement systems were assessed according to 81060 standards.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026