Evaluation of Regional Ventilation Distribution in Patients Affected by Abdominal Sepsis After Emergent Laparotomy

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Regional Ventilation Distribution in Patients Affected by Abdominal Sepsis After Emergent Laparotomy

Conditions
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Abdominal Sepsis, Acute Respiratory Failure, Ventilation Therapy; Complications, Emergencies

Intervention / Treatment
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* Diagnostic Test: Arterial blood gas analysis
* Diagnostic Test: Venous blood gas analysis
* Diagnostic Test: Esophageal pressure monitoring
* Diagnostic Test: Intrabdominal pressure
* Diagnostic Test: Electrical impedance tomopgraphy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open Abdomen<br> | Diagnostic Test: Arterial blood gas analysis<br>* 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.<br>Diagnostic Test: Venous blood gas analysis<br>* 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.<br>Diagnostic Test: Esophageal pressure monitoring<br>* The researchers will position an esophageal balloon to evaluate esophageal pressure<br>Diagnostic Test: Intrabdominal pressure<br>* The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .<br>Diagnostic Test: Electrical impedance tomopgraphy<br>* The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure<br>|
| Other: Closed Abdomen<br> | Diagnostic Test: Arterial blood gas analysis<br>* 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.<br>Diagnostic Test: Venous blood gas analysis<br>* 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.<br>Diagnostic Test: Esophageal pressure monitoring<br>* The researchers will position an esophageal balloon to evaluate esophageal pressure<br>Diagnostic Test: Intrabdominal pressure<br>* The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .<br>Diagnostic Test: Electrical impedance tomopgraphy<br>* The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator | 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). | Day 0 | 
| Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator | 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). | Day 1 | 
| Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator | 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). | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional ventilation distribution measured using Electrical impedance tomography | 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 | Day 0 | 
| Regional ventilation distribution measured using Electrical impedance tomography | 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 | Day 1 | 
| Regional ventilation distribution measured using Electrical impedance tomography | 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 | Day 2 | 
| Mortality in the intensive care unit | Mortality rate in ICU | Up to 28 days | 
| Infection rate during ICU stay | New diagnosis of infections during the ICU stay | Up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical impedance tomography, Emergent laparotomy, Compliance partinioning