A-line/CareTaker Comparison Study in ICU Patients

Blood Pressure Clinical Trial

Official title:

A-line/CareTaker Comparison Study in ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479724
• Other study ID #: ETC_CareTaker_01
• Status: Completed
• Phase: N/A
• First received: June 22, 2015
• Last updated: June 22, 2015
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2015
• Source: Empirical Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• continuous non-invasive blood pressure monitor
continuous blood pressure monitoring using device in parallel with Gold Standard (A-line)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Empirical Technologies Corporation	University of Virginia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No