Comparison of Cardiac Output Measurement Between Transpulmonary Thermodilution and Photoplethysmography

Hypovolemia Clinical Trial

— PANEX  

Official title:

Comparison of Cardiac Output Measurement Between Invasive Method (Transpulmonary Thermodilution) and Non Invasive Method (Photoplethysmography) : an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535703
• Other study ID #: 11-007
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: April 3, 2013
• Start date: November 2011
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypovolemia

Locations

Country	Name	City	State
France	University Hospital, Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion	No
Secondary	Bias and limits of agreement for change in arterial pressure measured by digital photoplethysmography compared with intra radial artery catheter during volume expansion	Analysis of agreement, bias and precision between arterial pressure from digital photoplethysmography and intra radial artery catheter	During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion	No
Secondary	Predictive value of fluid responsiveness by the variation of pulse pressure variation measuring by radial artery catheter and digital photoplethysmography	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	During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion	No
Secondary	Predictive value of fluid responsiveness by three different localisation of plethysmographic variability index sensor: forehead, digital and ear position	Analysis of the predictive value of fluid responsiveness with AUC receiving operating curve for each localisation of sensor of plethysmography variability index	During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion	No