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Sigh35 and End-expiratory Occlusion Test (EEOT) for Assessing flUid Responsiveness in Critically Ill Patients Undergoing Pressure Support Ventilation

Recruiting
2 recruiting sites
Start: Jun 4, 2021
NCTNCT04924920

This trial is currently recruiting participants

2 locations available for registration

Brief Summary

The application of a brief SIGH of 4 seconds at 35 cmH20 has shown to reliably predict fluid responsiveness in critically ill patients undergoing pressure support ventilation. The end-expiratory occlusion test (EEOT) has been also used in the same type of patients, with the same purpose, but in a limited amount of studies. The aim of this study is to compare the reliability of the the two test in assessing fluid responsiveness.

Eligibility

Age Range

18 Years - N/A

Gender

All

Healthy Volunteers

Not Accepted

Detailed Criteria

* Adult (\>18 yo) ICU patients undergoing PSV ventilation * Inspiratory support level (PS) between 8 and 15 cmH2O and positive end-expiratory pressure (PEEP) between 5 and 12 cmH2O, * Presence of acute circulatory failure defined as: * Systolic blood pressure (SBP) ≤90 mmHg or mean arterial pressure (MAP) ≤70 mmHg or requiring vasopressors to maintain SBP \>90 mmHg or MAP \>70 mmHg or decline of SBP \> 50 mm Hg in known hypertensive patients, along with one or more of the following: * urinary flow ≤0.5 mL/kg/min for ≥2 hours * heart rate ≥100 beats per minute * presence of skin mottling and 4) blood lactate concentration ≥4 mmol/L. Exclusion criteria * left ventricular ejection fraction \<30% or severe valvular dysfunction * atrial fibrillation * severe acute respiratory distress syndrome (ARDS) * abdominal compartment syndrome * air leakage through chest drains * artifacts in arterial waveform * pathological respiratory patterns due to neurological diseases * signs of fatigue or respiratory distress

Conditions

Critically Ill PatientsHemodynamic InstabilityMechanical Ventilation Pressure High

Interventions

SIGH

To add the Sigh35 to PSV, the ventilator is set in pressure controlled synchronized intermittent mandatory ventilation plus PSV \[SIMV (PC) + PS mode\], with SIMV rate set a 1/min and inspiratory time of 4 seconds. SIMV (PC) = 35 cmH20 of total inspiratory support (PEEP + PS).

DIAGNOSTIC_TEST

EEOT

• The EEOT is performed by interrupting the mechanical ventilation for 15 seconds, by using and end-expiratory hold on the ventilator. The ventilator trigger is set at 2 L/min.

DIAGNOSTIC_TEST

Fluid challenge

Bolus of fluids of 4 ml/kg given within 10 minutes

DIAGNOSTIC_TEST

Trial Locations

2 locations currently accepting registrations. Choose a recruiting location below to register your interest.

Humanitas Research Hospital

Rozzano, Milano, Italy

Recruiting

Humanitas Research Hospital

Rozzano, Milano, Italy

Recruiting

Sponsor Information

Lead Sponsor

Humanitas Clinical and Research Center

Type: OTHER