Measurement of Pulse Pressure Variation and Cardiac Output by a New Application for Android™ (Captesia™)

Coronary Bypass Clinical Trial

Official title:

Measurement of Pulse Pressure Variation (PPV) and Cardiac Output (CO) by a New Application for Android™ (Captesia™) : Comparison With PPV and CO Obtained by a Method of Transpulmonary Thermodilution.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692222
• Other study ID #: B406201526827
• Status: Completed
• Phase: N/A
• First received: February 10, 2016
• Last updated: December 6, 2016
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Observational

Clinical Trial 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.

Description:

Pulse pressure variation (PPV) remains a good predictor of fluid responsiveness in the OR. However, PPV can be time-consuming to calculate (manual determination), is not always displayed on monitoring screens nor reliable through visual assessment and needs additional devices to be displayed. A new Android application (Captesia) automatically calculates the PPV utilizing a digital photograph of the arterial waveform from the monitor. The application determines the PPV by selecting peaks and troughs of the arterial curve.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients scheduled for coronary artery bypass

Exclusion Criteria:

• patients with arrhythmias like atrial fibrillation

• patients with valvular insufficiency

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Bypass

Intervention

Other:
• Calculation of PPV and CO with two methods

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	CO	the Cardiac Output will be calculated by the Android Application (Captesia) and by thermodilution before and after of volume expansion, which goal is to change the cardiac output.	at time of surgery	No