Non-invasive Assessment of Arterial Blood Pressure and Fu... | NCT01292759

Studies
Non-invasive Assessment of Arterial Blood Pressure and Functional Hemodynamic Parameters

NCT01292759

Sponsor

Johannes Gutenberg University Mainz

Status

Unknown status

Last Update Posted

Feb 15, 2011Estimated

Enrollment

24Estimated

Phase

Not provided

Conditions

Surgical Procedure, Unspecified

Interventions

Not provided

Countries

Germany

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

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 9, 2011

First Submission Date that Met QC Criteria

Feb 9, 2011

First Posted Date

Feb 10, 2011Estimated

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

Feb 14, 2011

Last Update Posted Date

Feb 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cardiac output can be monitored using different invasive devices. Nexfin HD is a new, noninvasive device that uses model flow technology to measure stroke volume and thus computes cardiac output (CO). To evaluate this new device the investigators compared esophageal doppler CO to Nexfin HD CO in patients scheduled for elective abdominal surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

24Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 and < 80 years old
Written informed consent obtained

Exclusion Criteria:

Renal failure
Heart failure (EF < 25%)
Peripheral artery occlusion disease
M. Raynaud
Rhythms other than sinus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for elective abdominal surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Anaesthesiology der Universitätsmedizin Mainz	Recruiting	Mainz		55131	Germany