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

NCT06495489 | Completed

• 1 other identifier: PO23139
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Critically Ill Patients With Hypovolemia

Keywords

Pulse Pressure; Pulse Pressure Variation; Passive Leg Raising; Echocardiography; Preload dependency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluate the diagnostic performance of the increase in pulse pressure (PP) during a PLR test to predict preload responsiveness

  Day 1

• Compare PLR measurements other hemodynamic data

  Day 1

Study Arms (2)

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

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

Interventions

Detection of preload responders by a PLR test OTHER

Detection of preload dependency by using PLR test and echocardiography

Negative PLR test (PLR-); Positive PLR test (PLR +)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Related Publications (2)

• 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.

  PMID: 36116288 BACKGROUND

• 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.

  PMID: 34246460 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: July 10, 2024
• Study Start: January 29, 2024
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

FR (1)