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

NCT03066388 | Terminated DMC

• 2 other identifiers: 2011_472011-A01599-32
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• respiratory variations in noninvasive pulse pressure with respect to the response to fluid

  during 30 minutes of the volume expansion

Study Arms (1)

Pulse pressure variations

EXPERIMENTAL

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

Interventions

Pulse pressure variations OTHER

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.

Pulse pressure variations

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Intensive Care Department, Salengro Hospital,CHRU

Lille, France

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Shock

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sébastien Preau, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: February 28, 2017
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 28, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)