CNAP Accuracy Dependent on Hemodynamic Variables

Accuracy and Precision of Noninvasive Measurement Clinical Trial

Official title:

Accuracy of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Measurements Dependent on Cardiac Function, Vascular Resistance and Volume Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743846
• Other study ID #: CNAP 2010_3
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: December 5, 2015
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• need for invasive blood pressure measurement

Exclusion Criteria:

• age under 18

• emergencies

• cardiac dysrhythmia

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Accuracy and Precision of Noninvasive Measurement

Locations

Country	Name	City	State
Germany	University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial pressure	Accuracy and precision of CNAP in comparison with the gold standard	intraoperative	No