Blood PressureNCT02479724
A-line/CareTaker Comparison Study in ICU Patients
An observational study of Blood Pressure, run by Empirical Technologies Corporation.
Trial summary
Comparison of Blood Pressures obtained with the Pulse Decomposition Algorithm and Intra-Arterial Catheters in ICU Patients Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- continuous non-invasive blood pressure monitor
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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)
Who may be able to join
- male or female age 18 to 45
- presence of a radial arterial catheter
- informed consent by subject or surrogate
- available digital pulse
Who cannot join
- failure to meet all of the inclusion criteria
About this study
Comparison of Blood Pressures obtained with the Pulse Decomposition Algorithm and Intra-Arterial Catheters in ICU Patients
Read the 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).
- Conditions
- Blood Pressure
- Being tested
- continuous non-invasive blood pressure monitor
- Keywords
- continuous, non-invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous non-invasive blood pressure monitorDevice
continuous blood pressure monitoring using device in parallel with Gold Standard (A-line)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Empirical Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
- Investigators
- Martin C. Baruch, PhD, Principal investigator, Empirical Technologies Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479724
- Sponsor's protocol ID
- ETC_CareTaker_01
- Status last verified
- Jun 2015
- First submitted
- 22 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A-line/CareTaker Comparison Study in ICU Patients
- ClinicalTrials.gov ID
- NCT02479724
- Acronym / sponsor ID
- ETC_CareTaker_01
- Conditions
- Blood Pressure
- Keywords
- continuous, non-invasive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Empirical Technologies CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (4 listed)
- male or female age 18 to 45
- presence of a radial arterial catheter
- informed consent by subject or surrogate
- available digital pulse
Key exclusion criteria (1 listed)
- failure to meet all of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous non-invasive blood pressure monitorcontinuous blood pressure monitoring using device in parallel with Gold Standard (A-line) | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin C. Baruch, PhD principal investigator
Empirical Technologies Corporation
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Empirical Technologies Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance comparison according to AAMI/ANSI/ISO 81060-1:2013 (time frame: 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.