Clinical trial NCT01535703: Comparison of Cardiac Output Measurement Between Transpulmonary Thermodilution and Photoplethysmography
Official title: Comparison of Cardiac Output Measurement Between Invasive Method (Transpulmonary Thermodilution) and Non Invasive Method (Photoplethysmography) : an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovolemia
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion
Secondary outcomes:
measure: Bias and limits of agreement for change in arterial pressure measured by digital photoplethysmography compared with intra radial artery catheter during volume expansion
timeFrame: During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion
measure: Predictive value of fluid responsiveness by the variation of pulse pressure variation measuring by radial artery catheter and digital photoplethysmography
timeFrame: During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion
measure: Predictive value of fluid responsiveness by three different localisation of plethysmographic variability index sensor: forehead, digital and ear position
timeFrame: During admission in ICU after cardiac surgery and before spontaneous breathing-measurements will be complete within 60 minutes of starting fluid expansion
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital, Caen
Study officials:
affiliation: University Hospital, Caen
name: Marc-Olivier Fischer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: