Abdominal Sepsis, Acute Respiratory Failure, Ventilation Therapy; Complications, Emergencies
Conditions
Keywords
Electrical impedance tomography, Emergent laparotomy, Compliance partinioning
Brief summary
The goal of this clinical trial is to evaluate regional ventilation distribution in patients admitted to the intensive care unit after emergent laparotomy due to abdominal sepsis. The main question it aims to answer is: • evaluate if patients admitted after an open abdomen strategy have a different regional ventilation distribution compared to patients in which abdomen is closed at the end of the procedure Participants will undergo non-invasive monitoring (esophageal pressure and electrical impedance tomography) and an blood gas analysis samples. Researchers will compare open abdomen group and closed abdomen group to see if the ventilation distribution pattern is different.
Interventions
DIAGNOSTIC_TESTArterial blood gas analysis
The researches will collect 2 ml of arterial blood using an arterial line already in place for clinical purposes to perform and arterial gas analysis.
DIAGNOSTIC_TESTVenous blood gas analysis
The researches will collect 2 ml of arterial blood using a central venous line already in place for clinical purposes to perform a gas analysis.
DIAGNOSTIC_TESTEsophageal pressure monitoring
The researchers will position an esophageal balloon to evaluate esophageal pressure
DIAGNOSTIC_TESTIntrabdominal pressure
The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .
DIAGNOSTIC_TESTElectrical impedance tomopgraphy
The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure
Sponsors
University of Milan
Università degli Studi di Ferrara
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 and \< 90 years * Admitted to the ICU after emergent laparotomy for abdominal sepsis * Acute respiratory failure
Exclusion criteria
* Controindications to electrical impedance tomography monitoring * body mass index \> 40 kg/m2 * Haemodinamic instability * Pneumothorax - Pneumomediastinum * refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator | Day 0 | Different chest wall compliance between the two groups measured using the esophageal catheter. Chest wall compliance will be calculated using the data provided from the respiratory monitoring (i.e. esophageal balloon catheter). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Regional ventilation distribution measured using Electrical impedance tomography | Day 0 | The researchers will evaluate differences in ventilation distribution pattern among the different weaning trials using Electrical Impedance Tomography and focusing on: Regional ventilation distribution Regional inhomogeneity Regional compliance distribution Center of Ventilation Regional ventilation delay Regional compliance |
| Mortality in the intensive care unit | Up to 28 days | Mortality rate in ICU |
| Infection rate during ICU stay | Up to 28 days | New diagnosis of infections during the ICU stay |
Countries
Italy
Contacts
Primary ContactGaetano Scaramuzzo
Outcome results
None listed