TerminatedNot Applicable

Comparison of Non-invasive Vs. Invasive Hemodynamic Measurements

Stopped: Study was terminated due to inability of clinical site to enroll sufficient number of subjects

United States8 participantsStarted 2020-01-16

Plain-language summary

Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Non-invasive pressure indicator

Timeframe: 12-72 hours

Trial details

NCT IDNCT04180202

SponsorNihon Kohden

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-06-20

View on ClinicalTrials.gov More Heart Failure，Congestive trials