Sigh35 and End-expiratory Occlusion Test (EEOT) for Assessing flUid Responsiveness in Critically Ill Patients Undergoing Pressure Support Ventilation
Launched by HUMANITAS CLINICAL AND RESEARCH CENTER · Jun 11, 2021
Trial Information
Current as of June 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two tests that help doctors understand how well critically ill patients respond to fluids while on a type of breathing support called pressure support ventilation. One test is called the Sigh35, which involves a short, controlled breath that lasts four seconds, and the other is the end-expiratory occlusion test (EEOT). The goal is to see which of these tests works better at predicting whether a patient will benefit from receiving fluids.
To participate in this trial, patients need to be adults over 18 years old who are in the intensive care unit (ICU) and are receiving pressure support ventilation. They should also be experiencing significant blood pressure issues, which can include symptoms like a very low blood pressure or needing medications to keep their blood pressure stable. Participants can expect to undergo these two tests during their stay in the ICU, and the results will help improve care for patients in similar situations. It's important to note that some patients may not qualify for the study due to certain heart or respiratory conditions.
Gender
ALL
Eligibility 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
About Humanitas Clinical And Research Center
Humanitas Clinical and Research Center is a leading institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. Located in Italy, the center specializes in conducting high-quality clinical trials across various therapeutic areas, including oncology, cardiology, and neurology. With a commitment to scientific excellence and ethical standards, Humanitas collaborates with academic institutions, pharmaceutical companies, and healthcare organizations to foster groundbreaking discoveries and improve patient outcomes. The center's multidisciplinary team of experts leverages state-of-the-art facilities and cutting-edge technologies to ensure rigorous study design and execution, ultimately contributing to the advancement of medical knowledge and the development of new therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rozzano, Milano, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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