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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01535703
First Posted: February 20, 2012
Last Update Posted: April 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Caen
  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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01535703     History of Changes
Other Study ID Numbers: 11-007
First Submitted: February 7, 2012
First Posted: February 20, 2012
Last Update Posted: April 4, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Hypovolemia
Pathologic Processes