Arterial Pressure Derived Dynamic Parameters to Detect Preload Responsiveness in Mechanically Ventilated Patients Under Spontaneous Mode
NCT Number: NCT06495489
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: General Critically Ill Patients With Hypovolemia
Interventions: OTHER: Detection of preload responders by a PLR test
Sponsor: CHU de Reims
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-29
Completion Date: 2024-12
Locations: Chu Reims, Reims, 51092, France

Summary:
The management of septic shock patients includes the infusion of fluids, however fluids may be deleterious if the patient does not respond by increasing cardiac output. By consequence, it is now recommended to predict the fluid response (fluid or preload responsiveness) before infusing them. In this protocol, the investigators will include critically ill patients mechanically ventilated patients under a spontaneous mode, for whom the physician in charge has decided to test preload responsiveness. The investigators will collect from the continuous monitoring of arterial pressure of the patient the Pulse Pressure (PP) which is the difference between systolic arterial pressure and diastolic arterial pressure and the Pulse Pressure Variation (PPV) automatically displayed by the monitor in addition to other clinical (hemodynamic, respiratory) parameters. After one minute of Passive Leg Raising manoeuvre (PLR) the investigators collect the same parameters and the investigators will compare the changes of these parameters in patients who are preload responsive to patients who are not. Preload responsiveness will be defined by echocardiographic parameters before and during PLR. More exactly, a surrogate of cardiac output measured by echocardiography wich is VTI of the sub-aorti flow; an increase of more than 12% defines apreload responsive patient.

Primary Outcome Measures: Diagnostic performance of the decrease in Pulse Pressure Variation (PPV) during a Passive Leg Raising test (PLR) to predict preload responsiveness, To assess the diagnostic performance of the decrease in Pulse Pressure Variation (PPV) during a Passive Leg Raising test (PLR) to predict preload responsiveness in mechanically ventilated patients under spontaneous mode hospitalized in intensive care. PPV, baseline values will be collected before passive leg raising (as displayed by our routine monitoring devices) and at one minute of the PLR manoeuvre. The difference between these two parameters will be calculated and entered into our database for each patient and a ROC curve analysis of this new parameter will be performed within a binary classification model by plotting the True Positive Rate (TPR) against the False Positive Rate (FPR) at different threshold settings. This will give us the ability of this new parameter to discriminate patients who are preload responders from those who are not, and ultimately a new cut-off value., Day 1
Secondary Outcome Measures: Evaluate the diagnostic performance of the increase in pulse pressure (PP) during a PLR test to predict preload responsiveness, Evaluate the diagnostic performance of the increase in pulse pressure (PP) during a PLR test to predict preload responsiveness in mechanically ventilated patients under spontaneous mode hospitalized in intensive care. For this PP, baseline values will be calculated as the difference between the systolic arterial pressure (SAP) and diastolic arterial pressure (DAP) before passive leg raising and at one minute of the PLR maneuver. The difference between these two parameters (at baseline and at one minute of the PLR maneuver) will be calculated and entered into our database for each patient and a ROC curve analysis of this new parameter will be performed in order to give us the ability of this new parameter to discriminate patients who are preload responders from those who are not, and ultimately a new cut-off value., Day 1|Compare PLR measurements other hemodynamic data, Compare before/after PLR measurements other hemodynamic data (Blood pressure, cardiac output, heart rate). Differences between baseline parameters (SAP, DAP, MAP, Cardiac output and HR) and at one minute PLR maneuver will be calculated and ROC curve analysis of this new parameter will be performed in order to give us the ability of this new parameter to discriminate patients who are preload responders from those who are not, and ultimately a new cut-off value., Day 1