Heart Failure，CongestiveNCT04180202
Comparison of Non-invasive Vs. Invasive Hemodynamic Measurements
An observational study of Heart Failure，Congestive, run by Nihon Kohden at 1 site in United States.
Trial summary
Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure，Congestive
- What is being tested?
- Non-invasive central venous pressure
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2020to 20 Jun 2022
- 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: Patients admitted to the El Camino Hospital ICU with central venous catheter.
Who may be able to join
- Adult age over 18 years.
- Arm circumference is 23 cm to 55 cm
- Subject will have an existing central venous catheter during their ICU stay
- Subject or legally authorized representative (LAR) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent
- Subject or LAR is willing and able to comply with protocol procedures
Who cannot join
- Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff.
- Pregnant (self-reported)
- Upper extremity deep venous thrombosis currently being treated
- Severe skin disease involving the upper arm(s)
- Study investigator may exclude patients based on clinical judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Study of EzCVP and CVP
Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.
Read the detailed description
The conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. To overcome this challenge, a new technology to assess CVP non-invasively using an oscillometric method is being developed. It is called enclosed zone central venous pressure (ezCVP). A comparison study of ezCVP and CVP is needed to determine accuracy and reproducibility.
- Conditions
- Heart Failure，Congestive
- Being tested
- Non-invasive central venous pressure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive central venous pressureDevice
Also called ezCVP, CVPni
Non-invasive method to measure central venous pressure indicator
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive pressure indicator
Evaluate sensitivity and specificity of ezCVP indication based on the case where CVP is in a 'low range' (0 < CVP < 10 mmHg) or 'high range' (>= 10 mmHg)
Measured: 12-72 hours
Secondary outcomes (2)
Direction of change
Correlate the directionality of ezCVP change to invasive CVP change over time (i.e., increasing, decreasing or remaining stable).
Measured: 12-72 hours
Correlation with invasive CVP
Quantify the agreement between ezCVP (non-invasive) and CVP (invasive)
Measured: 12-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start16 Jan 2020
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Why it stopped: Study was terminated due to inability of clinical site to enroll sufficient number of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure，CongestiveStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon Kohden
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zachary Edmonds, MD, Principal investigator, Palo Alto Foundation Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180202
- Sponsor's protocol ID
- CS-014-001
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2019
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only summary data of participants will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of EzCVP and CVP
- ClinicalTrials.gov ID
- NCT04180202
- Acronym / sponsor ID
- CS-014-001
- Conditions
- Heart Failure，Congestive
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated due to inability of clinical site to enroll sufficient number of subjects
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Nihon KohdenIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 27 Nov 2019 (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.
Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.
Detailed description
The conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. To overcome this challenge, a new technology to assess CVP non-invasively using an oscillometric method is being developed. It is called enclosed zone central venous pressure (ezCVP). A comparison study of ezCVP and CVP is needed to determine accuracy and reproducibility.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the El Camino Hospital ICU with central venous catheter.
Key inclusion criteria (5 listed)
- Adult age over 18 years.
- Arm circumference is 23 cm to 55 cm
- Subject will have an existing central venous catheter during their ICU stay
- Subject or legally authorized representative (LAR) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent
- Subject or LAR is willing and able to comply with protocol procedures
Key exclusion criteria (5 listed)
- Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff.
- Pregnant (self-reported)
- Upper extremity deep venous thrombosis currently being treated
- Severe skin disease involving the upper arm(s)
- Study investigator may exclude patients based on clinical judgement
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 |
|---|---|---|
| Non-invasive central venous pressureAlso: ezCVP, CVPniNon-invasive method to measure central venous pressure indicator | Device | – |
Primary outcome
Non-invasive pressure indicator
Time frame: 12-72 hours
Evaluate sensitivity and specificity of ezCVP indication based on the case where CVP is in a 'low range' (0 < CVP < 10 mmHg) or 'high range' (>= 10 mmHg)
2 secondary outcomes
Direction of change
Time frame: 12-72 hours
Correlation with invasive CVP
Time frame: 12-72 hours
Results and safety
The study was stopped early (reason given: Study was terminated due to inability of clinical site to enroll sufficient number of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. Only summary data of participants will be shared.
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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.
Zachary Edmonds, MD principal investigator
Palo Alto Foundation Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure，Congestive, run by Nihon Kohden 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 5 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 27 Dec 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 was stopped early (reason given: Study was terminated due to inability of clinical site to enroll sufficient number of subjects). 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?
Non-invasive pressure indicator (time frame: 12-72 hours). 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 27 Dec 2024.