UnknownNot Applicable

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

Italy60 participantsStarted 2022-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pulse pressure prediction of fluid responsiveness

Timeframe: Evaluated before and after SIGH35 (within 1 minute from SIGH35 application)

Stroke volume prediction of fluid responsiveness

Timeframe: Evaluated before and after SIGH35 (within 1 minute from SIGH35 application)

Trial details

NCT IDNCT04924920

SponsorHumanitas Clinical and Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More Critically Ill Patients trials