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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

Tracking Information
First Submitted Date  ICMJE November 9, 2016
First Posted Date  ICMJE February 28, 2017
Last Update Posted Date February 28, 2017
Study Start Date  ICMJE April 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2017)
respiratory variations in noninvasive pulse pressure with respect to the response to fluid [ Time Frame: during 30 minutes of the volume expansion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accuracy of Pulse Pressure Variations Measured by a Non Invasive Digital Device to Predict Fluid Responsiveness
Official Title  ICMJE Accuracy of Pulse Pressure Variations Measured by a Non Invasive Digital Device to Predict Fluid Responsiveness in Patients With Systemic Inflammatory Response Syndrome
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Systemic Inflammatory Response Syndrome
  • Circulatory Failure
  • Mechanical Ventilation
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: Pulse pressure variations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 23, 2017)
6
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03066388
Other Study ID Numbers  ICMJE 2011_47
2011-A01599-32 ( Other Identifier: ID-RCB number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sébastien Preau, MD,PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP