NCT01743846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

1.5 years

First QC Date

December 4, 2012

Last Update Submit

December 5, 2015

Conditions

Accuracy and Precision of Noninvasive Measurement

Outcome Measures

Primary Outcomes (1)

  • arterial pressure

    Accuracy and precision of CNAP in comparison with the gold standard

    intraoperative

Study Arms (1)

Major Surgery

Patients undergoing major surgery

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing major surgery under general anaesthesia

You may qualify if:

  • need for invasive blood pressure measurement

You may not qualify if:

  • age under 18
  • emergencies
  • cardiac dysrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine

Kiel, 24106, Germany

Location

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med Jochen Renner

Study Record Dates

First Submitted

December 4, 2012

First Posted

December 6, 2012

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

DE(1)