Hemodynamic MonitoringNCT02950649
Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Perioperative Care
An observational study of Hemodynamic Monitoring, run by Loma Linda University at 3 sites in United States.
Trial summary
This project is designed to assess the impact of pre-operative use of non-invasive hemodynamic monitoring technologies on improving peri-operative and post-operative care of moderate to high-risk surgical patients with poor functional status by improving the detection of reduced cardiovascular function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Monitoring
- What is being tested?
- invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards Lifesciences and No Hemodynamic Monitored Guided Assesment
- Type of treatment
- Medical device
- How many people
- 189 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Nov 2016to 14 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with ASA classification level 3 and 4, with less than 5 metabolic events
Who may be able to join
- Adult patients (greater than 18 years of age)
- ASA classification 3 and 4 level patients with poor functional status,
- less than 5 metabolic equivalents (METs) -
Who cannot join
- < 18 years of age, pregnancy,
- known severe peripheral artery disease,
- poor perfusion to fingers (as defined as a perfusion index less than 0.5%- www.Masimo.com),
- history of Raynaud's,
- refusal to provide written consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Loma Linda Health
Loma Linda, California, 92354
Loma Linda University Department of Anesthesiology
Loma Linda, California, 92354
Pat Moore
Loma Linda, California, 92354
About this study
Official title: Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Perioperative Care in Moderate to High Risk Patients With Poor Functional Status
This project is designed to assess the impact of pre-operative use of non-invasive hemodynamic monitoring technologies on improving peri-operative and post-operative care of moderate to high-risk surgical patients with poor functional status by improving the detection of reduced cardiovascular function.
Read the detailed description
This study seeks to evaluate the impact of using a non-invasive technology to assess flow guided parameters (SV,SVR, dp/dt, CO, etc.) on patient care decisions in the preoperative settings. Patients seen in the preoperative clinic who are undergoing a moderate or high-risk procedure and have less than 4 metabolic equivalents (METs) will be approached to participate in the study .
Once consented, the device will be placed during the preoperative clinic visit and the data will be presented to the care team. Surveys will be completed by the health care provider for each consented patient to determine if the data from the device positively impacted patient care decisions. Specifically, the survey will evaluate if providing information on the patient's cardiovascular function (via the device used for this study) facilitated the health care provider to identify if the patient had reduced cardiovascular function. For the primary outcome, this study will evaluate if this device can assistant the identification of patients with reduced cardiovascular function by providing the flow guided parameter listed above. Secondary markers include the evaluation of perioperative complication rate (composite outcome ) between those that had the non-invasive HD data displayed to the preoperative team vs. not. Additional secondary makers will include: frequency of intraoperative hemodynamic optimization and goal directed fluid therapy administration, health care provider survey results, patient survey on the level of discomfort from wearing the cuff during the study. length of hospital stay, length of intensive care stay, readmission to the hospital within 30 days after hospital discharge, and 30-day postoperative mortality.
Outcome data will be collected using the electronic medical records database available at the investigators institution.
It is the hope of the investigators that this study will demonstrate that by simply applying the preoperative use of the non-invasive hemodynamic technologies one can:
- more appropriately identify which patients would benefit from intraoperative hemodynamic monitoring strategies
- increase satisfaction of the preoperative assessment by the health care provider
- further validate the importance of caring for patients with knowledge of their volume status, contractility, and vascular resistance in other patient care settings.
- Conditions
- Hemodynamic Monitoring
- Being tested
- invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards Lifesciences, No Hemodynamic Monitored Guided Assesment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards LifesciencesDevice
Experimental: Hemodynamic Monitored Guided Assesment This group will have the non-invasive hemodynamic monitoring device placed and its data will help guide (intervention) patient's management decisions (experimental).
No Hemodynamic Monitored Guided AssesmentDevice
Arm: Active Comparator: No Hemodynamic Monitored Guided Assesment This group will have the non-invasive hemodynamic monitoring device placed but its data will NOT be factored for intervention of the patient's management decisions.
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic Monitored Guided Assesment | This group will have the non-invasive hemodynamic monitoring device placed and the data will be used for comparison with routine subjective preoperative assessment assessment. Receives: Device: invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards Lifesciences | |
| No Hemodynamic Monitored Guided Assesment | This group will have subjective assessment by the provider and this data will be compared to the device assessment of cardiac index.. Receives: Device: No Hemodynamic Monitored Guided Assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of subjective assessment compared to device assessment of cardiac index
Comparison of cardiac index derived from subjective preoeprative assessment to cardiac index derived from device assessment
Measured: Up to one year from date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start17 Nov 2016
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Why it stopped: PI left institution 10/01/2020 and no further subjects were enrolled and no further data was collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic MonitoringStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Melissa McCabe, Loma Linda University
- Investigators
- Davinder Ramsingh, MD, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950649
- Sponsor's protocol ID
- 5160227
- Status last verified
- Apr 2022
- First submitted
- 3 Aug 2016
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Perioperative Care in Moderate to High Risk Patients With Poor Functional Status
- ClinicalTrials.gov ID
- NCT02950649
- Acronym / sponsor ID
- 5160227
- Conditions
- Hemodynamic Monitoring
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution 10/01/2020 and no further subjects were enrolled and no further data was collected.
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 17 Nov 2016 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 1 Nov 2016 (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.
This project is designed to assess the impact of pre-operative use of non-invasive hemodynamic monitoring technologies on improving peri-operative and post-operative care of moderate to high-risk surgical patients with poor functional status by improving the detection of reduced cardiovascular function.
Detailed description
This study seeks to evaluate the impact of using a non-invasive technology to assess flow guided parameters (SV,SVR, dp/dt, CO, etc.) on patient care decisions in the preoperative settings. Patients seen in the preoperative clinic who are undergoing a moderate or high-risk procedure and have less than 4 metabolic equivalents (METs) will be approached to participate in the study .
Once consented, the device will be placed during the preoperative clinic visit and the data will be presented to the care team. Surveys will be completed by the health care provider for each consented patient to determine if the data from the device positively impacted patient care decisions. Specifically, the survey will evaluate if providing information on the patient's cardiovascular function (via the device used for this study) facilitated the health care provider to identify if the patient had reduced cardiovascular function. For the primary outcome, this study will evaluate if this device can assistant the identification of patients with reduced cardiovascular function by providing the flow guided parameter listed above. Secondary markers include the evaluation of perioperative complication rate (composite outcome ) between those that had the non-invasive HD data displayed to the preoperative team vs. not. Additional secondary makers will include: frequency of intraoperative hemodynamic optimization and goal directed fluid therapy administration, health care provider survey results, patient survey on the level of discomfort from wearing the cuff during the study. length of hospital stay, length of intensive care stay, readmission to the hospital within 30 days after hospital discharge, and 30-day postoperative mortality.
Outcome data will be collected using the electronic medical records database available at the investigators institution.
It is the hope of the investigators that this study will demonstrate that by simply applying the preoperative use of the non-invasive hemodynamic technologies one can:
- more appropriately identify which patients would benefit from intraoperative hemodynamic monitoring strategies
- increase satisfaction of the preoperative assessment by the health care provider
- further validate the importance of caring for patients with knowledge of their volume status, contractility, and vascular resistance in other patient care settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic Monitored Guided Assesment | – | Device: invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards LifesciencesThis group will have the non-invasive hemodynamic monitoring device placed and the data will be used for comparison with routine subjective preoperative assessment assessment. |
| No Hemodynamic Monitored Guided Assesment | – | Device: No Hemodynamic Monitored Guided AssesmentThis group will have subjective assessment by the provider and this data will be compared to the device assessment of cardiac index.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with ASA classification level 3 and 4, with less than 5 metabolic events
Key inclusion criteria (3 listed)
- Adult patients (greater than 18 years of age)
- ASA classification 3 and 4 level patients with poor functional status,
- less than 5 metabolic equivalents (METs) -
Key exclusion criteria (5 listed)
- < 18 years of age, pregnancy,
- known severe peripheral artery disease,
- poor perfusion to fingers (as defined as a perfusion index less than 0.5%- www.Masimo.com),
- history of Raynaud's,
- refusal to provide written consent
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 |
|---|---|---|
| invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards LifesciencesExperimental: Hemodynamic Monitored Guided Assesment This group will have the non-invasive hemodynamic monitoring device placed and its data will help guide (intervention) patient's management decisions (experimental). | Device | Hemodynamic Monitored Guided Assesment |
| No Hemodynamic Monitored Guided AssesmentArm: Active Comparator: No Hemodynamic Monitored Guided Assesment This group will have the non-invasive hemodynamic monitoring device placed but its data will NOT be factored for intervention of the patient's management decisions. | Device | No Hemodynamic Monitored Guided Assesment |
Primary outcome
Accuracy of subjective assessment compared to device assessment of cardiac index
Time frame: Up to one year from date of randomization
Comparison of cardiac index derived from subjective preoeprative assessment to cardiac index derived from device assessment
Results and safety
The study was stopped early (reason given: PI left institution 10/01/2020 and no further subjects were enrolled and no further data was collected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Davinder Ramsingh, MD principal investigator
Loma Linda University Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Monitoring, run by Loma Linda University at 3 sites 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was stopped early (reason given: PI left institution 10/01/2020 and no further subjects were enrolled and no further data was collected.). Results are not available in the source record.
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?
Accuracy of subjective assessment compared to device assessment of cardiac index (time frame: Up to one year from date of randomization). 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 21 Apr 2022.