Comparison of Non-invasive Vs. Invasive Hemodynamic Measu... | NCT04180202

Studies
Comparison of Non-invasive Vs. Invasive Hemodynamic Measurements

NCT04180202

Sponsor

Nihon Kohden

Status

Terminated

Last Update Posted

Dec 27, 2024Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Heart Failure，Congestive

Interventions

Non-invasive central venous pressure

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Jan 16, 2020Actual

Primary Completion Date

Jun 20, 2022Actual

Completion Date

Jun 20, 2022Actual

First Submitted Date

Nov 25, 2019

First Submission Date that Met QC Criteria

Nov 25, 2019

First Posted Date

Nov 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2024

Last Update Posted Date

Dec 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-invasive central venous pressure	Device	Non-invasive method to measure central venous pressure indicator		ezCVP CVPni

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	12-72 hours

Secondary Outcomes

Measure	Description	Time Frame
Direction of change	Correlate the directionality of ezCVP change to invasive CVP change over time (i.e., increasing, decreasing or remaining stable).	12-72 hours
Correlation with invasive CVP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to the El Camino Hospital ICU with central venous catheter.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zachary Edmonds, MD	Palo Alto Foundation Medical Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
El Camino Hospital		Mountain View	California	94040	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Only summary data of participants will be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases