NCT02692222

Brief Summary

This study test the agreement and accuracy of Pulse Pressure Variation (PPV) and Cardiac Output (CO) obtained by the Android application Capstesia™ against the gold standard : PPV and CO calculated by thermodilution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

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

Study Start

First participant enrolled

February 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

10 months

First QC Date

February 10, 2016

Last Update Submit

December 6, 2016

Conditions

Coronary Bypass

Keywords

pulse pressure variation monitoringCaptesiacardiac output monitoring

Outcome Measures

Primary Outcomes (1)

  • PPV

    the Pulse Pressure Variation will be calculated by the Android Application (Captesia) and by the Picco before and after a meneuver of volume expansion, which goal is to change the cardiac output.

    at time of surgery

Secondary Outcomes (1)

  • CO

    at time of surgery

Study Arms (1)

PPV

This study will track changes in PPV and CO before and after of volume expansion, which goal is to change the cardiac output.

Other: Calculation of PPV and CO with two methods

Interventions

Calculation of PPV and CO with two methodsOTHER
PPV

Eligibility Criteria

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

patients scheduled for coronary artery bypass

You may qualify if:

  • patients scheduled for coronary artery bypass

You may not qualify if:

  • patients with arrhythmias like atrial fibrillation
  • patients with valvular insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

Related Publications (2)

  • Yang X, Du B. Does pulse pressure variation predict fluid responsiveness in critically ill patients? A systematic review and meta-analysis. Crit Care. 2014 Nov 27;18(6):650. doi: 10.1186/s13054-014-0650-6.

    PMID: 25427970BACKGROUND

  • Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.

    PMID: 21705869BACKGROUND

Study Officials

  • Céline F Boudart, MD

    Erasme Hospital Bruxelles

    PRINCIPAL INVESTIGATOR

  • Alexandre Joosten, MD

    Erasme Hospital Bruxelles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 26, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

BE(1)