Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480942
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-10
Brief Title:
Arterial Pressure Derived Dynamic Parameters to Detect Preload Responsiveness in Spontaneously Breathing Patients
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
The Performance of Changes of Pulse Pressure and of Pulse Pressure Variation to Detect Preload Responsiveness in Spontaneously Breathing Patients
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 spontaneously breathing 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 pressurePP 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 de 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
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 spontaneously breathing patients 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 beforeafter 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
Andor other signs of hemodynamic instability tachycardia mottling oliguria hyperlactatemia
In spontaneous ventilation and without ventilatory assistance
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 contraindicationimpossibility 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 hisher relatives if heshe is unable to express their will of the objectives and the progress of the study If the patient or hisher 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 conventional oxygen therapy or High Flow Fio2 or liter O2min Flow if applicable
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 spontaneously breathing patients 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 beforeafter 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
Andor other signs of hemodynamic instability tachycardia mottling oliguria hyperlactatemia
In spontaneous ventilation and without ventilatory assistance
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 contraindicationimpossibility 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 hisher relatives if heshe is unable to express their will of the objectives and the progress of the study If the patient or hisher 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 conventional oxygen therapy or High Flow Fio2 or liter O2min Flow if applicable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None