Hemodynamic MonitoringNCT04858126
Accuracy of ECOM Plus Versus Pulmonary Artery Catheter
A study testing ECOM cardiac output in people with Hemodynamic Monitoring, run by ECOM Medical, Inc. at 1 site in United States.
Trial summary
This Study will compare the accuracy of the ECOM Plus Endotracheal Cardiac Output Monitor (ECOM) without the use of the arterial pressure waveform from the arterial line to 1) the current clinical standard of cardiac output measured by intermittent room temperature bolus thermodilution using a PAC, 2) the current ECOM… 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?
- ECOM cardiac output
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 11 Sep 2023
- 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
- Patients able to give informed consent.
- Patients undergoing surgery that would routinely require use of an endotracheal, pulmonary artery catheter and arterial catheter.
Who cannot join
- Patients who do not speak English.
- Patients not competent to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of the ECOM Plus Hemodynamic Monitor Versus Pulmonary Artery Catheter
This Study will compare the accuracy of the ECOM Plus Endotracheal Cardiac Output Monitor (ECOM) without the use of the arterial pressure waveform from the arterial line to 1) the current clinical standard of cardiac output measured by intermittent room temperature bolus thermodilution using a PAC, 2) the current ECOM System with the use of the arterial blood pressure waveform from a radial arterial line and 3) the Flo-Trac® System.
Read the detailed description
This Study will compare the accuracy of the ECOM Plus Endotracheal Cardiac Output Monitor (ECOM) without the use of the arterial pressure waveform from the arterial line to 1) the current clinical standard of cardiac output measured by intermittent room temperature bolus thermodilution using a PAC, 2) the current ECOM System with the use of the arterial blood pressure waveform from a radial arterial line and 3) the Flo-Trac® System (Edwards LifeSciences).
- Conditions
- Hemodynamic Monitoring
- Being tested
- ECOM cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECOM cardiac outputDevice
Measure cardiac output during perioperative period and compare to pulmonary artery catheter thermal dilution cardiac output measurement.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Experimental | ECOM endotracheal cardiac output monitor in patients undergoing cardiac and liver surgery. Receives: Device: ECOM cardiac output |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ECOM Plus impedance and thermal dilution cardiac output measurements
Correlation via linear regression between thermal dilution and ECOM Plus included as an "R" to coefficient. Cardiac output measured by thermal dilution and impedance cardiography. Management of the patients using standard thermal dilution derived CO measurement only. The ECOM Plus measurement output are for research purposes only and not to be used in the management of the patient. ECOM Plus impedance cardiography measured in the ICU when routine thermal dilution CO measurements are made. Continued impedance measurements until tracheal extubation.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jan 2021
- Primary completion11 Sep 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic MonitoringStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOM Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur Wallace, MD, Principal investigator, VA San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858126
- Sponsor's protocol ID
- ECOM SP 20-007
- Status last verified
- Jan 2023
- First submitted
- 21 Apr 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data and information for 510(k).
Publications
Wallace AW, Salahieh A, Lawrence A, Spector K, Owens C, Alonso D. Endotracheal cardiac output monitor. Anesthesiology. 2000 Jan;92(1):178-89. doi: 10.1097/00000542-200001000-00030.
PubMed 10638915
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the ECOM Plus Hemodynamic Monitor Versus Pulmonary Artery Catheter
- ClinicalTrials.gov ID
- NCT04858126
- Acronym / sponsor ID
- ECOM SP 20-007
- Conditions
- Hemodynamic Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- ECOM Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 26 Apr 2021 (actual)
- 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 Study will compare the accuracy of the ECOM Plus Endotracheal Cardiac Output Monitor (ECOM) without the use of the arterial pressure waveform from the arterial line to 1) the current clinical standard of cardiac output measured by intermittent room temperature bolus thermodilution using a PAC, 2) the current ECOM System with the use of the arterial blood pressure waveform from a radial arterial line and 3) the Flo-Trac® System.
Detailed description
This Study will compare the accuracy of the ECOM Plus Endotracheal Cardiac Output Monitor (ECOM) without the use of the arterial pressure waveform from the arterial line to 1) the current clinical standard of cardiac output measured by intermittent room temperature bolus thermodilution using a PAC, 2) the current ECOM System with the use of the arterial blood pressure waveform from a radial arterial line and 3) the Flo-Trac® System (Edwards LifeSciences).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Experimental | Device: ECOM cardiac outputECOM endotracheal cardiac output monitor in patients undergoing cardiac and liver surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients able to give informed consent.
- Patients undergoing surgery that would routinely require use of an endotracheal, pulmonary artery catheter and arterial catheter.
Key exclusion criteria (2 listed)
- Patients who do not speak English.
- Patients not competent to give informed 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 |
|---|---|---|
| ECOM cardiac outputMeasure cardiac output during perioperative period and compare to pulmonary artery catheter thermal dilution cardiac output measurement. | Device | Single Group Assignment |
Primary outcome
Comparison of ECOM Plus impedance and thermal dilution cardiac output measurements
Time frame: 6 months.
Correlation via linear regression between thermal dilution and ECOM Plus included as an "R" to coefficient. Cardiac output measured by thermal dilution and impedance cardiography. Management of the patients using standard thermal dilution derived CO measurement only. The ECOM Plus measurement output are for research purposes only and not to be used in the management of the patient. ECOM Plus impedance cardiography measured in the ICU when routine thermal dilution CO measurements are made. Continued impedance measurements until tracheal extubation.
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 20 Feb 2024.
- Background: PubMed 10638915Wallace AW, Salahieh A, Lawrence A, Spector K, Owens C, Alonso D. Endotracheal cardiac output monitor. Anesthesiology. 2000 Jan;92(1):178-89. doi: 10.1097/00000542-200001000-00030.
- Individual participant dataSharing planned: No. Data and information for 510(k).
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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.
Arthur Wallace, MD principal investigator
VA San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECOM cardiac output in people with Hemodynamic Monitoring, run by ECOM Medical, Inc. 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 2 inclusion and 2 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 20 Feb 2024. 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?
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?
Comparison of ECOM Plus impedance and thermal dilution cardiac output measurements (time frame: 6 months.). 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 NCT04858126, which also lists 1 linked publication.
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 20 Feb 2024.