Does high abdominal pressure cause microaspiration in ventilated patients with cirrhosis?
Official title: Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients
Run by University Hospital, Lille · NCT04530760 · Data updated 2026-11-12
We will see if high pressure inside the belly leads to more microaspiration in adults with cirrhosis who are on mechanical ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 226 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 2 sites (Lille and 1 other locations) |
| Status | Recruiting |
| Started | October 8, 2021 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT04530760 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with cirrhosis who are intubated and receiving mechanical ventilation and in whom intra-vesical pressure can be measured are the ideal candidates.
✕Probably not a fit
Patients who are not intubated, do not have cirrhosis, are pregnant, are oliguric, or cannot undergo bladder pressure measurement are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study monitors intra-abdominal pressure by measuring bladder (intra-vesical) pressure every eight hours during the first two days of mechanical ventilation. Tracheal suction samples will be tested for pepsin or amylase to define microaspiration. Patients will be grouped by presence or absence of intra-abdominal hypertension (IAH) and compared for rates of microaspiration. Eligible participants are adult patients with cirrhosis who are intubated and can have intra-vesical pressure measured, excluding pregnant or oliguric patients.
Why it matters
Potential benefit: If a link is found, identifying IAH could help clinicians target prevention efforts to reduce aspiration-related lung complications in ventilated cirrhotic patients.
How similar studies have gone: Measuring bladder pressure for IAH and using pepsin or amylase to detect microaspiration have been used in critical care research before, but data specifically focused on cirrhotic patients are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patients * Cirrhosis * intubation and mechanical ventilation Exclusion Criteria: * pregnancy * oliguric patients * impossibility to measure intravesical pressure
Where it's running
-
Hop Claude Huriez Chu Lille
Lille, France Recruiting -
Hop Salengro - Hopital B
Lille, France Recruiting
Study contacts
- Principal investigator: Saad Nseir, MD,PhD — University Hospital, Lille
- Study coordinator: Saad Nseir, MD,PhD
- Email: saadalla.nseir@chru-lille.fr
- Phone: 0320444495
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.