Low Cardiac OutputNCT02529033
Hemodynamic Survey Cardiac Surgical Scenarios
An observational study of Low Cardiac Output, run by University of Iowa.
Trial summary
The purpose of this study is to find out the Lidco Rapid ( monitoring tool gives cardiac output) is as equivalent in determining the hemodynamic assessment in cardiac surgical scenarios as the most often used pulmonary artery catheter, which is much more invasive than the Lidco Rapid. Read more about this study
- Who is it for?
- Ages 28 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Cardiac Output
- What is being tested?
- LIDCO Rapid, Pulmonary artery catheter
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to May 2016
- 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 28 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cardiac Fellowship trained Anesthesiologists
Who may be able to join
- Must be a certified Anesthesiologist with cardiac fellowship training
Who cannot join
- none
About this study
Official title: Comparative Hemodynamic Assessment Between Lidco Rapid and Pulmonary Artery Thermodilution
The purpose of this study is to find out the Lidco Rapid ( monitoring tool gives cardiac output) is as equivalent in determining the hemodynamic assessment in cardiac surgical scenarios as the most often used pulmonary artery catheter, which is much more invasive than the Lidco Rapid. This will be accomplished through online surveys which have different cardiac surgery scenarios and will be distributed to cardiac fellowship trained anesthesiologists. The online based survey will include a specific scenario and details on the scenario represented in image format and a brief description of the patient to aid with their analysis of the situation.
Read the detailed description
Data from PA catheter such as PA pressure, pulmonary wedge pressure and cardiac output has been widely used in the various clinical situations warranting advance hemodynamic monitoring. It is considered as gold standard but unfortunately there is always risk associated with PA catheter and time lag between the clinical events and interpretation. Lidco Rapid is one of the non-invasive hemodynamic tools to measure various parameters. It is widely used in the intensive care set up for goal directed therapy but unfortunately there is not enough data to show whether it is useful in various peri-operative clinical conditions. In the online based survey, responses from the participants are recorded in the nominal scale ( 1 to 5 where 3 represents near normal). This survey will help to determine whether Investigators can replace the Lidco in any clinical situation warranting advance hemodynamic monitoring.
No previous study was done to specifically find out the hemodynamic component that differs between these tools intraoperatively in varying hemodynamic conditions during cardiac surgery although there were few studies compared the trend in the cardiac output with difference in opinion on their accuracy.
- Conditions
- Low Cardiac Output
- Being tested
- LIDCO Rapid, Pulmonary artery catheter
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIDCO Rapid, Pulmonary artery catheterDevice
Hemodynamic monitoring systems
What is being measured
The primary outcome is the main question the study is designed to answer.
To expect difference is within 1 unit ( scale of 1 to 5) in the hemodynamic assessment preferably preload , afterload and contractility between Lidco and data from PA catheter in different cardiac surgical patient scenarios.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Cardiac OutputStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sudhakar Subramani, M.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529033
- Sponsor's protocol ID
- 201504777
- Status last verified
- May 2023
- First submitted
- 3 Aug 2015
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hadian M, Kim HK, Severyn DA, Pinsky MR. Cross-comparison of cardiac output trending accuracy of LiDCO, PiCCO, FloTrac and pulmonary artery catheters. Crit Care. 2010;14(6):R212. doi: 10.1186/cc9335. Epub 2010 Nov 23.
PubMed 21092290Broch O, Renner J, Hocker J, Gruenewald M, Meybohm P, Schottler J, Steinfath M, Bein B. Uncalibrated pulse power analysis fails to reliably measure cardiac output in patients undergoing coronary artery bypass surgery. Crit Care. 2011;15(1):R76. doi: 10.1186/cc10065. Epub 2011 Feb 28.
PubMed 21356060
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Hemodynamic Assessment Between Lidco Rapid and Pulmonary Artery Thermodilution
- ClinicalTrials.gov ID
- NCT02529033
- Acronym / sponsor ID
- 201504777
- Conditions
- Low Cardiac Output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Aug 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.
The purpose of this study is to find out the Lidco Rapid ( monitoring tool gives cardiac output) is as equivalent in determining the hemodynamic assessment in cardiac surgical scenarios as the most often used pulmonary artery catheter, which is much more invasive than the Lidco Rapid. This will be accomplished through online surveys which have different cardiac surgery scenarios and will be distributed to cardiac fellowship trained anesthesiologists. The online based survey will include a specific scenario and details on the scenario represented in image format and a brief description of the patient to aid with their analysis of the situation.
Detailed description
Data from PA catheter such as PA pressure, pulmonary wedge pressure and cardiac output has been widely used in the various clinical situations warranting advance hemodynamic monitoring. It is considered as gold standard but unfortunately there is always risk associated with PA catheter and time lag between the clinical events and interpretation. Lidco Rapid is one of the non-invasive hemodynamic tools to measure various parameters. It is widely used in the intensive care set up for goal directed therapy but unfortunately there is not enough data to show whether it is useful in various peri-operative clinical conditions. In the online based survey, responses from the participants are recorded in the nominal scale ( 1 to 5 where 3 represents near normal). This survey will help to determine whether Investigators can replace the Lidco in any clinical situation warranting advance hemodynamic monitoring.
No previous study was done to specifically find out the hemodynamic component that differs between these tools intraoperatively in varying hemodynamic conditions during cardiac surgery although there were few studies compared the trend in the cardiac output with difference in opinion on their accuracy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 28 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac Fellowship trained Anesthesiologists
Key inclusion criteria (1 listed)
- Must be a certified Anesthesiologist with cardiac fellowship training
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| LIDCO Rapid, Pulmonary artery catheterHemodynamic monitoring systems | Device | – |
Primary outcome
To expect difference is within 1 unit ( scale of 1 to 5) in the hemodynamic assessment preferably preload , afterload and contractility between Lidco and data from PA catheter in different cardiac surgical patient scenarios.
Time frame: intraoperative
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 16 May 2023.
- Background: PubMed 21092290Hadian M, Kim HK, Severyn DA, Pinsky MR. Cross-comparison of cardiac output trending accuracy of LiDCO, PiCCO, FloTrac and pulmonary artery catheters. Crit Care. 2010;14(6):R212. doi: 10.1186/cc9335. Epub 2010 Nov 23.
- Background: PubMed 21356060Broch O, Renner J, Hocker J, Gruenewald M, Meybohm P, Schottler J, Steinfath M, Bein B. Uncalibrated pulse power analysis fails to reliably measure cardiac output in patients undergoing coronary artery bypass surgery. Crit Care. 2011;15(1):R76. doi: 10.1186/cc10065. Epub 2011 Feb 28.
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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.
Sudhakar Subramani, M.D. principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
An observational study of Low Cardiac Output, run by University of Iowa.
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 1 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 16 May 2023. 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?
To expect difference is within 1 unit ( scale of 1 to 5) in the hemodynamic assessment preferably preload , afterload and contractility between Lidco and data from PA catheter in different cardiac surgical patient scenarios. (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529033, which also lists 2 linked publications.
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 May 2023.