HypotensionNCT02473588
Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output
A study testing Retia Medical Long Time Interval Analysis in people with Hypotension, run by University of Virginia at 1 site in United States.
Trial summary
A group of engineers at Michigan State developed a novel waveform analysis technique ("Long Time Interval Analysis" [LTIA]) that attempts to estimate cardiac output non-invasively. Retrospective comparison of LTIA to invasive techniques (e.g. thermodilution) suggest acceptable agreement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- Retia Medical Long Time Interval Analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 years or older)
- Undergoing hepatobiliary surgery (open or laparoscopic) requiring general anesthesia as part of the patient's clinical care
- Attending anesthesiologist plans to place an intra-arterial catheter for routine care
- Attending anesthesiologist believes that non-invasive cardiac output monitoring would benefit the patient
Who cannot join
- Minors (17 years or younger)
- Parturient (pregnant women)
- Cognitively impaired
- Unable to sign informed consent form
- Prisoner
- Prior esophageal surgery
Show all 9Show fewer
- Moderate to severe aortic regurgitation
- Mechanical cardiac support (e.g., intra-aortic balloon pump)
- Severe, persistent arrhythmias
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22908
Robert H Thiele, M.D., 434-243-9412, rht7w@virginia.edu
About this study
Official title: Comparison of Retia Medical (Long Time Interval Analysis) to Deltex Esophageal Doppler for Cardiac Output Measurement
A group of engineers at Michigan State developed a novel waveform analysis technique ("Long Time Interval Analysis" [LTIA]) that attempts to estimate cardiac output non-invasively. Retrospective comparison of LTIA to invasive techniques (e.g. thermodilution) suggest acceptable agreement. Thus, a prospective trial of LTIA is warranted. This study compares LTIA to a validated measure of cardiac output - esophageal Doppler monitoring.
- Conditions
- Hypotension
- Being tested
- Retia Medical Long Time Interval Analysis
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retia Medical Long Time Interval AnalysisDevice
Retia Medical "Long Time Interval Analysis" will be used to analyze the blood pressure tracing of patients having surgery who have an arterial catheter
| Study group | Role | What they receive |
|---|---|---|
| LTIA Group | Other | Patients in the LTIA Group (all patients) will have blood pressure recorded continuously. LTIA will be used to measure stroke volume and cardiac output after the completion of data collection Receives: Device: Retia Medical Long Time Interval Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pearson Correlation Coefficient
Correlation between change in CO from LTIA vs. change in CO from esophageal Doppler
Measured: Data collected in first 20 minutes of anesthesia/surgery will be recorded; Pearson correlation coefficient will be calculated after all 60 subjects have been enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Thiele, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473588
- Sponsor's protocol ID
- 18022
- Status last verified
- Jun 2015
- First submitted
- 11 Jun 2015
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Retia Medical (Long Time Interval Analysis) to Deltex Esophageal Doppler for Cardiac Output Measurement
- ClinicalTrials.gov ID
- NCT02473588
- Acronym / sponsor ID
- 18022
- Conditions
- Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 16 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.
A group of engineers at Michigan State developed a novel waveform analysis technique ("Long Time Interval Analysis" [LTIA]) that attempts to estimate cardiac output non-invasively. Retrospective comparison of LTIA to invasive techniques (e.g. thermodilution) suggest acceptable agreement. Thus, a prospective trial of LTIA is warranted. This study compares LTIA to a validated measure of cardiac output - esophageal Doppler monitoring.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LTIA Group | Other | Device: Retia Medical Long Time Interval AnalysisPatients in the LTIA Group (all patients) will have blood pressure recorded continuously. LTIA will be used to measure stroke volume and cardiac output after the completion of data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (18 years or older)
- Undergoing hepatobiliary surgery (open or laparoscopic) requiring general anesthesia as part of the patient's clinical care
- Attending anesthesiologist plans to place an intra-arterial catheter for routine care
- Attending anesthesiologist believes that non-invasive cardiac output monitoring would benefit the patient
Key exclusion criteria (9 listed)
- Minors (17 years or younger)
- Parturient (pregnant women)
- Cognitively impaired
- Unable to sign informed consent form
- Prisoner
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 |
|---|---|---|
| Retia Medical Long Time Interval AnalysisRetia Medical "Long Time Interval Analysis" will be used to analyze the blood pressure tracing of patients having surgery who have an arterial catheter | Device | LTIA Group |
Primary outcome
Pearson Correlation Coefficient
Time frame: Data collected in first 20 minutes of anesthesia/surgery will be recorded; Pearson correlation coefficient will be calculated after all 60 subjects have been enrolled
Correlation between change in CO from LTIA vs. change in CO from esophageal Doppler
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
Related trials for Hypotension
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retia Medical Long Time Interval Analysis in people with Hypotension, run by University of Virginia at 1 site in United States.
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 9 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: status not confirmed, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert H Thiele, M.D. (434-243-9412, rht7w@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pearson Correlation Coefficient (time frame: Data collected in first 20 minutes of anesthesia/surgery will be recorded; Pearson correlation coefficient will be calculated after all 60 subjects have been enrolled). 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 16 Jun 2015.