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Completed

NCT Number: NCT01535703

Comparison of Cardiac Output Measurement Between Transpulmonary Thermodilution and Photoplethysmography

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.

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Key information

Conditions

Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Caen

Caen, 14000, France

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: PANEX

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Feb 20, 2012
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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