Does high abdominal pressure cause microaspiration in ventilated patients with cirrhosis?
Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients
University Hospital, Lille · NCT04530760
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 |
|---|---|
| Enrollment | 226 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University Hospital, Lille (other) |
| Locations | 2 sites (Lille and 1 other locations) |
| Trial ID | NCT04530760 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lille and 1 other locations
- 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
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: Critical Illness, Cirrhosis, Liver