Comparison of Cardiac Output Measurement Between Transpulmonary Thermodilution and Photoplethysmography (PANEX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01535703
First received: February 7, 2012
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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.


Condition
Hypovolemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Cardiac Output Measurement Between Invasive Method (Transpulmonary Thermodilution) and Non Invasive Method (Photoplethysmography) : an Observational Study

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • 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 [ Time Frame: During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion ] [ Designated as safety issue: No ]
    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:
  • Bias and limits of agreement for change in arterial pressure measured by digital photoplethysmography compared with intra radial artery catheter during volume expansion [ Time Frame: During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion ] [ Designated as safety issue: No ]
    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 [ Time Frame: During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion ] [ Designated as safety issue: No ]
    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 [ Time Frame: During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion ] [ Designated as safety issue: No ]
    Analysis of the predictive value of fluid responsiveness with AUC receiving operating curve for each localisation of sensor of plethysmography variability index


Enrollment: 50
Study Start Date: November 2011
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Post cardiac surgery intensive care patients with arterial pressure monitoring and transpulmonary thermodilution monitoring with indication of fluid challenge.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535703

Locations
France
University Hospital, Caen
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Marc-Olivier Fischer, M.D. University Hospital, Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01535703     History of Changes
Other Study ID Numbers: 11-007
Study First Received: February 7, 2012
Last Updated: April 3, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hypovolemia
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014