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Accuracy of Pulse Pressure Variations Measured by a Non Invasive Digital Device to Predict Fluid Responsiveness

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ClinicalTrials.gov Identifier: NCT03066388
Recruitment Status : Terminated (insufficient inclusion rate)
First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

It has been well established that only 40 to 60% of the patients hospitalized for inflammatory response syndrome (SIRS) positively respond to volume expansion (VE). The fluid responsiveness is usually estimated by assessing VE-induced change in stroke volume (SV). To guide prescriptions and possibly avoid deleterious effects of inappropriate VE, several clinical studies demonstrated that invasive dynamic indices based on heart-lung interactions permit an accurate prediction of the hemodynamic effects induced by VE.

Mechanical ventilation induces cyclic changes in intrathoracic and transpulmonary pressures that transiently affect venous return, right and left ventricular preload, resulting in pronounced cyclic changes in SV in preload-dependent, but not in preload-independent patients. These cyclic changes in SV can be evaluated by the cyclic changes in arterial pulse pressure. Several studies have shown that pulse pressure variation is able to predict fluid responsiveness in patients in the operating room and intensive care unit (ICU).

However, this technique requires percutaneous arterial catheterization, which is associated with several rare but serious complications (thrombosis, infections, pseudoaneurysm,hematoma, and bleeding).

A method for assessing noninvasive arterial blood pressure using an electropneumatic control loop was introduced by Penaz in 1973. Briefly, the blood volume in a finger is measured and kept constant by applying corresponding external pressure. The continuously changing external pressure needed to keep the volume constant directly corresponds to the arterial pressure and, therefore can be used as continuous measurement of arterial blood pressure. Numerous studies evaluating the accuracy of this technology, e.g., Finapres™ (Ohmeda Monitoring Systems, Englewood, CO), and more recently of the Infinity CNAP™ SmartPod (Dräger Medical AG & Co.KG, Lübeck, Germany).

The basic operating principle of the CNAP™ is similar to the Finapres™, but CNAP™ uses multiple control loops. It has recently been shown that CNAP provides real-time estimates of mean arterial blood pressure (MAP) comparable with those measured by an invasive intraarterial catheter system during general anaesthesia.

The accuracy of the measures and the respiratory variations in pulse pressure obtained with the CNAP system have not yet been studied in ICU.


Condition or disease Intervention/treatment Phase
Systemic Inflammatory Response Syndrome Circulatory Failure Mechanical Ventilation Other: Pulse pressure variations Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Accuracy of Pulse Pressure Variations Measured by a Non Invasive Digital Device to Predict Fluid Responsiveness in Patients With Systemic Inflammatory Response Syndrome
Study Start Date : April 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: Pulse pressure variations
Pulse pressure variations, stroke volume, systemic arterial pressure, heart rate, and respiratory rate are recorded immediately before and after volume expansion (VE), performed as a 30-minute infusion of 500 mL of 4% gelatin. Pulse pressure variations are obtained by noninvasive (ΔPPCNAP) and invasive (ΔPPART) devices.
Other: Pulse pressure variations
Stroke volume and, pulse pressure variations obtained by noninvasive (ΔPPCNAP) and invasive (ΔPPART) devices are recorded immediately before and after volume expansion (VE), performed as a 30-minute infusion of 500 mL of 4% gelatin.




Primary Outcome Measures :
  1. respiratory variations in noninvasive pulse pressure with respect to the response to fluid [ Time Frame: during 30 minutes of the volume expansion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients of the intensive care units of the Lille university-hospital.
  • Age greater than or equal to 18.
  • Patient insured
  • Mechanical ventilation without spontaneous respiratory cycles
  • Regular cardiac rhythm
  • Prescription by the physician in charge of the patients of a 500 mL volume expansion in less than 30 minutes.
  • Patients with sepsis with at least one sign of acute circulatory failure:

    • Tachycardia with heart rate> 100/min
    • systolic blood pressure <90mmHg or a decrease >40mmHg in previously hypertense patient
    • Oliguria <0.5ml/kg/hour for at least one hour
    • skin mottling

Exclusion Criteria:

  • high-grade aortic insufficiency
  • transthoracic echogenicity unsuitable for measuring the stroke volume by echo-Doppler
  • Spontaneous breathing
  • clinical or ultrasonographic evidence of pulmonary edema due to heart failure
  • pregnancy
  • abdominal compartment syndrome
  • Irregular cardiac rhythm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066388


Locations
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France
Intensive Care Department, Salengro Hospital,CHRU
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Sébastien Preau, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03066388    
Other Study ID Numbers: 2011_47
2011-A01599-32 ( Other Identifier: ID-RCB number )
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
fluid
fluid responsiveness
pulse pressure
noninvasive monitoring
pulse pressure variations
volume expansion
SIRS
systemic inflammatory response syndrome
Additional relevant MeSH terms:
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Syndrome
Systemic Inflammatory Response Syndrome
Shock
Disease
Pathologic Processes
Inflammation