Effects of patient's inspiratory effort, as assessed by esophageal pressure, on Pulse Pressure Variation assessment of fluid responsiveness in patients undergoing mechanical ventilation.

Not Applicable

Recruiting

• Conditions: Critical illness; Hemodynamic status; Fluid responsiveness; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12616000529448
• Lead Sponsor: Federico Longhini, MD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

All patients 18 years/old or older undergoing invasive mechanical ventilation in Pressure Support mode (with a positive end-expiratory pressure between 4 and 6 cmH2O and a Pressure Support between 8 and 12 cmH2O), with a clinical need for fluid infusion, i.e. systolic arterial blood pressure < 90 mmHg or 50 mmHg reduction of values in patients with chronic hypertension, oliguria as defined by a diuresis < 0.5 ml/kg/h in the 2 previous hours, need for inotropes (dopamine >5mcg*kg/min or norepinephrine), lactate > 2 mmol/L.

Exclusion Criteria

Patients will be excluded if meeting one or more off the following criteria: 1) cardiac arrhythmia; 2) atrial fibrillation or flutter; 3) patients undergoing any form of renal replacement therapy; 4) valvular defects of moderate to severe grade; 5) history of congestive cardiac failure; 6) previous or presence of pneumothorax or emphysema; 7) patients with Chronic Obstructive Pulmonary Disease (COPD); 8) patients with kyphoscoliosis; 9) use of expiratory muscles and 10) arterial partial pressure to inspired fraction of oxygen (PaO2/FiO2) ratio < 200.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effects of patient's inspiratory effort, as assessed by the esophageal pressure, on Pulse Pressure Variation ability to predict fluid responsiveness, as defined by an increment of the cardiac index > 15% after a fluid challenge, in patients undergoing partial ventilatory assistance at different levels of inspiratory support and different administered tidal volumes,[Record and analysis of the Pulse Pressure Variation and Esophageal Pressure values at each protocol trial. The definition of the patient as fluid responder will be given according to the modifications of the cardiac index after a 500ml of fluid challenge, after the trials of different ventilation settings.]

Secondary Outcome Measures

Name	Time	Method
To assess end-expiratory occlusion test reliability in predicting fluidresponsiveness, as defined by an increment of the cardiac index > 15% after a fluid challenge, in patients undergoing partial ventilatory assistance,[The End-expiratory occlusion test will be performed soon after esophageal catheter placement, (to assess its correct positioning). The values of Pulse Pressure Variation and Esophageal Pressure will be recorded at the end of each 5-minute trial and offline analyzed through a dedicated acquisition system.]