Accuracy of Pulse Pressure Variations Measured by a Non Invasive Digital Device to Predict Fluid Responsiveness
Primary Purpose
Systemic Inflammatory Response Syndrome, Circulatory Failure, Mechanical Ventilation
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pulse pressure variations
Sponsored by
About this trial
This is an interventional diagnostic trial for Systemic Inflammatory Response Syndrome focused on measuring fluid, fluid responsiveness, pulse pressure, noninvasive monitoring, pulse pressure variations, volume expansion, SIRS, systemic inflammatory response syndrome
Eligibility 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
Sites / Locations
- Intensive Care Department, Salengro Hospital,CHRU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulse pressure variations
Arm Description
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.
Outcomes
Primary Outcome Measures
respiratory variations in noninvasive pulse pressure with respect to the response to fluid
Secondary Outcome Measures
Full Information
NCT ID
NCT03066388
First Posted
November 9, 2016
Last Updated
February 23, 2017
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT03066388
Brief Title
Accuracy of Pulse Pressure Variations Measured by a Non Invasive Digital Device to Predict Fluid Responsiveness
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
insufficient inclusion rate
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Inflammatory Response Syndrome, Circulatory Failure, Mechanical Ventilation
Keywords
fluid, fluid responsiveness, pulse pressure, noninvasive monitoring, pulse pressure variations, volume expansion, SIRS, systemic inflammatory response syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulse pressure variations
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Pulse pressure variations
Intervention Description
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 Measure Information:
Title
respiratory variations in noninvasive pulse pressure with respect to the response to fluid
Time Frame
during 30 minutes of the volume expansion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Preau, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Department, Salengro Hospital,CHRU
City
Lille
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Accuracy of Pulse Pressure Variations Measured by a Non Invasive Digital Device to Predict Fluid Responsiveness
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