Comparison of Cardiac Output Measurement Between Transpulmonary Thermodilution and Photoplethysmography

Completed

• Conditions: Hypovolemia

• Registration Number: NCT01535703
• Lead Sponsor: University Hospital, Caen

Brief Summary

Monitoring could secure management for patient but stay invasive. The purpose of this study was to compare,after cardiac surgery, the cardiac output measurement between transpulmonary thermodilution(reference method) and digital photoplethysmography (non invasive) for absolute value and dynamics changes before and after fluid expansion for patients with indication of fluid challenge.

Detailed Description

* The time frame of the study period was included between the arrival at the ICU after cardiac surgery and before spontaneous breathing on mechanical ventilation

* Time-to-event outcome measures was period of time between the arrival at the ICU after cardiac surgery and before spontaneous breathing on mechanical ventilation. The event (hypotension) was defined as systolic arterial pressure under 90mmHg,less than 40mmHg, mean arterial pressure under 70mmHg, tachycardia upper 100 beats/min, presence of skin mottling, low cardiac output or previous blood loss.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-20
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-03
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Postcardiac surgery patients with arterial pressure monitoring and transpulmonary thermodilution monitoring with indication of fluid challenge
• Patients more than 18 years old

Exclusion Criteria

• Patients under 18 years old
• Pregnant women
• Patient without invasive monitoring
• Urgency surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation, percentage error, bias, precision and limits of agreement for change in cardiac output measured by digital photoplethysmography compared with transpulmonary thermodilution during fluid expansion	During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion	Analysis of correlation, percentage error, bias, precision and limits of agreement for change in cardiac output measured by digital photoplethysmography compared with transpulmonary thermodilution during fluid expansion

Secondary Outcome Measures

Name	Time	Method
Bias and limits of agreement for change in arterial pressure measured by digital photoplethysmography compared with intra radial artery catheter during volume expansion	During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion	Analysis of agreement, bias and precision between arterial pressure from digital photoplethysmography and intra radial artery catheter
Predictive value of fluid responsiveness by the variation of pulse pressure variation measuring by radial artery catheter and digital photoplethysmography	During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion	Analysis of the predictive value of fluid responsiveness with AUC receiving operating curve by the variation of pulse pressure variation measuring by radial artery catheter and digital photoplethysmography
Predictive value of fluid responsiveness by three different localisation of plethysmographic variability index sensor: forehead, digital and ear position	During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion	Analysis of the predictive value of fluid responsiveness with AUC receiving operating curve for each localisation of sensor of plethysmography variability index

Trial Locations

Locations (1)

University Hospital, Caen; 🇫🇷 Caen, France