Comparison of Noninvasive Vs. Invasive Hemodynamic Measurements

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-21

Study Completion Date

2026-10-19

Brief Summary

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

Detailed Description

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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

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Heart Failure, Congestive

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Non-invasive central venous pressure

Non-invasive method to measure central venous pressure indicator

Intervention Type DEVICE

Other Intervention Names

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ezCVP CVPni

Eligibility Criteria

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Inclusion Criteria

1. Adult age over 18 years.
2. Arm circumference is 18 cm to 55 cm
3. Subject will have an existing indwelling central venous catheter during their ICU stay
4. 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
5. Subject or LAR is willing and able to comply with protocol procedures

Exclusion Criteria

1. Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff.
2. Pregnant (self-reported)
3. Upper extremity deep venous thrombosis currently being treated
4. Severe skin disease involving the upper arm(s)
5. Study investigator may exclude patients based on clinical judgement

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Masataka Kawana, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University Hospital

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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74Ag- 00009

Identifier Type: -

Identifier Source: org_study_id