Assessing fluid responsiveness in critically ill patients using SIGH and EEOT
Sigh35 and End-expiratory Occlusion Test (EEOT) for Assessing flUid Responsiveness in Critically Ill Patients Undergoing Pressure Support Ventilation
NA · Humanitas Clinical and Research Center · NCT04924920
This study is testing two different methods to see which one better helps doctors determine if critically ill patients need more fluids while on breathing support.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Humanitas Clinical and Research Center (other) |
| Locations | 2 sites (Rozzano, Milano and 1 other locations) |
| Trial ID | NCT04924920 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the reliability of two tests, SIGH and the end-expiratory occlusion test (EEOT), in assessing fluid responsiveness in critically ill patients undergoing pressure support ventilation. The research focuses on patients with acute circulatory failure, utilizing dynamic indexes during controlled mechanical ventilation. By evaluating these tests, the study seeks to improve the assessment of preload dependence, which is crucial for effective fluid management in the ICU setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adult ICU patients over 18 years old who are undergoing pressure support ventilation with specific hemodynamic instability criteria.
Not a fit: Patients with severe left ventricular dysfunction, severe ARDS, or other significant respiratory or cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance fluid management strategies for critically ill patients, potentially improving their outcomes.
How similar studies have performed: Previous studies have shown success with similar approaches in assessing fluid responsiveness, although the specific comparison of SIGH and EEOT is less explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rozzano, Milano and 1 other locations
- Humanitas Research Hospital — Rozzano, Milano, Italy (RECRUITING)
- Humanitas Research Hospital — Rozzano, Milano, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Critically Ill Patients, Hemodynamic Instability, Mechanical Ventilation Pressure High