Arterial Pressure Derived Dynamic Parameters to Detect Preload Responsiveness in Mechanically Ventilated Patients Under Spontaneous Mode

The Performance of Changes of Pulse Pressure and of Pulse Pressure Variation to Detect Preload Responsiveness in Mechanically Ventilated Patients Under a Spontaneous Mode

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.

Study Overview

• Status: Completed
• Conditions: General Critically Ill Patients With Hypovolemia
• Intervention / Treatment: Other: Detection of preload responders by a PLR test

Detailed Description

*Objectives:

Primary : 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.

Secondary:

• Evaluate the diagnostic performance of the increase in Pulse Pressure (PP) during a PLR test to predict preload responsiveness in this same population.

• Compare before/after PLR measurements other hemodynamic data (blood pressure, cardiac output, heart rate).

  • Experimental scheme: it is a diagnostic and monocentric study.
  • Population / patients:

Inclusion criteria:

• Patient over 18 years old.
• Hospitalized in intensive care.

• For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:

  • Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.
  • And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia).
• In mechanically ventilated patients under spontaneous mode.
• Previously equipped with an arterial catheter.
• Affiliated to a social security scheme.

Non-inclusion criteria:

• Patient with arrythmia (PPV is not applicable).
• Patient with intra-abdominal hypertension (PLR test is not valid).
• Patient with a contraindication/impossibility to the PLR maneuver (lower limb amputation, respiratory intolerance).
• Patient with poor echogenicity noted previously.

• Patient protected by law.

  • Investigation Plan:

Patients meeting the inclusion criteria and not presenting any non-inclusion criteria may be included. The patient will be informed, or his/her relatives if he/she is unable to express their will, of the objectives and the progress of the study. If the patient, or his/her relatives, does not object to participate to the study, the course of the study will be as follows:

1. The following measurements will be performed before and after the PLR test in spontaneously breathing patients (SB) to evaluate the preload dependency:

   • Hemodynamic data: systolic (SAP), diastolic (DAP), mean (MAP), Pulse Pressure (PP), Heart Rate (HR), value of the Pulse Pressure Variation (PPV), Cardiac Index (CI) if cardiac output monitoring is already present.
   • Echographic data including: time-velocity integral of sub-aortic flow VTI Sub AO); aortic outflow chamber diameter (Diam outflow tract); data from the transmitral pulsed Doppler as well as the data from the tissue Doppler at the mitral annulus (E wave velocity; A wave; E' wave); left ventricular end-diastolic surface.
2. Collection of demographic parameters (age, sex, comorbidities), acute pathology and severity scores (SAPSII, APACHE II, SOFA) in the patient file.
3. Collection of oxygenation parameters: mode, Fio2 level od pressure support and of PEEP, in addition to the tidal volume and RR.

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• France
  • Reims, France, 51092
    • Chu Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

• Patient over 18 years old.
• Hospitalized in intensive care.

• For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:

  • Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.
  • And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia).
• In mechanically ventilated patients under spontaneous mode.
• Previously equipped with an arterial catheter.
• Affiliated to a social security scheme.

Description

Inclusion Criteria:

• Patient over 18 years old.
• Hospitalized in intensive care.

• For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:

  • Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.
  • And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia).
• In mechanically ventilated patients under spontaneous mode.
• Previously equipped with an arterial catheter.
• Affiliated to a social security scheme.

Exclusion Criteria:

• Patient with arrythmia (PPV is not applicable).
• Patient with intra-abdominal hypertension (PLR test is not valid).
• Patient with a contraindication/impossibility to the PLR maneuver (lower limb amputation, respiratory intolerance).
• Patient with poor echogenicity noted previously.
• Patient protected by law.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positive PLR test (PLR +); Patient over 18 years old.; Hospitalized in intensive care.; For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia) :; In mechanically ventilated patients under spontaneous mode.; Previously equipped with an arterial catheter.	Other: Detection of preload responders by a PLR test; Detection of preload dependency by using PLR test and echocardiography
Negative PLR test (PLR-); Patient over 18 years old.; Hospitalized in intensive care.; For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia) :; In mechanically ventilated patients under spontaneous mode.; Previously equipped with an arterial catheter.	Other: Detection of preload responders by a PLR test; Detection of preload dependency by using PLR test and echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CHU de Reims

Publications and helpful links

General Publications

• Shi R, Moretto F, Prat D, Jacobs F, Teboul JL, Hamzaoui O. Dynamic changes of pulse pressure but not of pulse pressure variation during passive leg raising predict preload responsiveness in critically ill patients with spontaneous breathing activity. J Crit Care. 2022 Dec;72:154141. doi: 10.1016/j.jcrc.2022.154141. Epub 2022 Sep 15.
• Hamzaoui O, Shi R, Carelli S, Sztrymf B, Prat D, Jacobs F, Monnet X, Gouezel C, Teboul JL. Changes in pulse pressure variation to assess preload responsiveness in mechanically ventilated patients with spontaneous breathing activity: an observational study. Br J Anaesth. 2021 Oct;127(4):532-538. doi: 10.1016/j.bja.2021.05.034. Epub 2021 Jul 8.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Actual): March 27, 2025
• Study Completion (Actual): March 27, 2025

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Echocardiography; Pulse Pressure Variation; Pulse Pressure; Preload dependency; Passive Leg Raising
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Hypovolemia
• Other Study ID Numbers: PO23139

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No