RecruitingACTRN12616000529448

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

Inspiratory effort and assessment of fluid responsiveness in mechanically ventilated patients.


Sponsor

Federico Longhini, MD

Enrollment

20 participants

Start Date

May 15, 2016

Study Type

Interventional

Conditions

Summary

The proper infusion of fluids is a challenge in critically ill patients undergoing partial support ventilation. The clinically used indexes for fluid-responsiveness are affected by several limitations. In the present study we hypothesized and aim to verify if pulse pressure variation can predict fluid responsiveness in patients undergoing different settings of assisted mechanical ventilation, and its relationship with the inspiratory effort, monitored with the esophageal pressure.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a measurement called pulse pressure variation (PPV) can reliably predict whether a critically ill patient on mechanical ventilation needs extra fluids. Getting fluid levels right in the ICU is very important — too little causes organ damage, too much can also be harmful. Researchers are also measuring the patient's own breathing effort using a small tube placed in the oesophagus to see how it affects the accuracy of PPV. You may be eligible if: - You are 18 years or older - You are on invasive mechanical ventilation in pressure support mode in an ICU - You have a clinical need for fluid — for example, low blood pressure, low urine output, or high lactate levels You may NOT be eligible if: - You have a heart rhythm problem, atrial fibrillation, or flutter - You are on any form of kidney dialysis - You have significant heart valve problems or a history of heart failure - You have COPD, lung disease, or a collapsed lung (pneumothorax) - Your oxygen levels are very poor (PaO2/FiO2 ratio below 200) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will be monitored with a monitor for hemodynamic assessment (Most Care, Vytech Health, Padova, Italy), which uses a Pressure Recording Analytical Method (PRAM). PRAM is a method designed fo

Patients will be monitored with a monitor for hemodynamic assessment (Most Care, Vytech Health, Padova, Italy), which uses a Pressure Recording Analytical Method (PRAM). PRAM is a method designed for arterial pressure-derived continuous Cardiac Output and it is the only methodology that does not need any starting calibration, central venous catheterization, or any adjustments based on experimental data. As a consequence, PRAM needs only an arterial line (radial, brachial, femoral) for working. Furthermore, we will position a catheter able to measure the esophageal pressure to properly assess the respiratory effort during the study protocol. The catheter will be connected to a dedicated pressure transducer and a recording system. In order to ascertain its correct positioning, an end-expiratory occlusion test will be performed. This test is used in spontaneously breathing patients, to validate the correct position of esophageal balloon; it is performed during an end-expiratory occlusion maneuver with the simultaneous measurement of the changes in airway and esophageal pressure during an inspiratory effort (i.e., no air flow) (Baydur’s occlusion test). The position of the esophageal catheter is considered acceptable when the ratio between the changes in two pressures is close to unity. In healthy subjects with or without anesthesia, when the esophageal catheter was correctly positioned, it has been found that the difference between the changes in esophageal and airway pressure was lower than 15 %. When the patient has been monitored with Most Care device, baseline data will be acquired for 2 minutes during Pressure Support Ventilation (PSV) without modification of the clinical settings. Afterwards, the patients will undergo to the following different ventilator settings lasting 5 minutes each according to computer generated random sequence: 1) PSV with a 50% increment of the baseline pressure support; 2) PSV with a 50% reduction of the baseline pressure support; 3) Assist/Controlled Ventilation with a tidal volume equal to 6 ml/kg of ideal body weight; 4) Assist/Controlled Ventilation with a tidal volume equal to 8 ml/kg of ideal body weight; 5) Assist/Controlled Ventilation with a tidal volume equal to 10 ml/kg of ideal body weight. Between each single trial of incremental pressures, a return to baseline conditions will be guarantee for 15 minutes, to avoid carry-over effects. In the end, after all the trials mentioned above, a single fluid challenge of 500 ml of normal saline will be infused in 5 minutes and the hemodynamic response will be evaluated to define if the patient is fluid responsive or not (i.e. if the cardiac index incremented of 15% at least, or not). All the conditions will be tested in one session and the entire study protocol will be conducted by one of the physicians involved in the research.


Locations(1)

Novara, Italy

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