CNAP Accuracy Dependent on Hemodynamic Variables | NCT01743846

Studies
CNAP Accuracy Dependent on Hemodynamic Variables

NCT01743846

Sponsor

University Hospital Schleswig-Holstein

Status

Completed

Last Update Posted

Dec 8, 2015Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Accuracy and Precision of Noninvasive Measurement

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

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Dec 4, 2012

First Submission Date that Met QC Criteria

Dec 4, 2012

First Posted Date

Dec 6, 2012Estimated

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 5, 2015

Last Update Posted Date

Dec 8, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Jochen Renner, PD Dr. med Jochen Renner, University Hospital Schleswig-HolsteinPrincipal Investigator

Lead Sponsor

University Hospital Schleswig-HolsteinOTHER

Collaborators

Not provided

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

Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic variables achieved by a PICCO monitor.

Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the accuracy of CNAP.

Detailed Description

Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic variables achieved by a PICCO monitor.

Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the accuracy of CNAP. Body mass index and age may have impact on the accuracy of PPV measured non-invasively on the basis of volume-clamp technique.

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

50Actual

Label	Type	Description	Intervention Names
Major Surgery		Patients undergoing major surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
arterial pressure	Accuracy and precision of CNAP in comparison with the gold standard	intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

need for invasive blood pressure measurement

Exclusion Criteria:

age under 18
emergencies
cardiac dysrhythmia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing major surgery under general anaesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jochen Renner, PD Dr.	University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine	Principal Investigator
Robert Hanss, Prof. Dr.	University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine		Kiel		24106	Germany