Last reviewed · How we verify
NCT04924920: SETUP
Sigh35 and End-expiratory Occlusion Test (EEOT) for Assessing flUid Responsiveness in Critically Ill Patients Undergoing Pressure Support Ventilation
NA trial testing SIGH in Critically Ill Patients in 60 participants. Status unknown.
1 October 2024
Quick facts
| Lead sponsor | Humanitas Clinical and Research Center |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 60 |
| Start date | 1 February 2022 |
| Primary completion | 1 October 2024 |
| Estimated completion | 1 October 2024 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- SIGH
- EEOT
- Fluid challenge — full drug profile →
Conditions studied
- Critically Ill Patients — all drugs for Critically Ill Patients →
- Hemodynamic Instability — all drugs for Hemodynamic Instability →
- Mechanical Ventilation Pressure High — all drugs for Mechanical Ventilation Pressure High →
Sponsor
Humanitas Clinical and Research Center
Who can join
18 and older, any sex, with Critically Ill Patients or Hemodynamic Instability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
SIGH<sub>35</sub> and end-expiratory occlusion test for assessing fluid responsiveness in critically ill patients undergoing pressure support ventilation.
Messina A, Calabrò L, Benedetto F, Villa A, et al · · 2025 · cited 2× · PMID 40317039 · DOI 10.1186/s13054-025-05398-4
Verify or expand the search:
- PubMed search for NCT04924920
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04924920 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Humanitas Clinical and Research Center
- Last refreshed: 2 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04924920.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing