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

Emergencies Clinical Trial

— CHESTOMY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05726500
• Other study ID #: CHESTOMY
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Università degli Studi di Ferrara
• Contact: Gaetano Scaramuzzo
• Phone: 0532238108
• Email: scrtn[@]unife.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Sepsis
• Acute Respiratory Failure
• Emergencies
• Intraabdominal Infections
• Respiratory Insufficiency
• Sepsis
• Toxemia
• Ventilation Therapy; Complications

Intervention

Diagnostic Test:
• Arterial 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.
• Venous 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.
• Esophageal pressure monitoring
The researchers will position an esophageal balloon to evaluate esophageal pressure
• Intrabdominal pressure
The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .
• Electrical impedance tomopgraphy
The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Sant'Anna	Ferrara

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara	University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Mortality in the intensive care unit	Mortality rate in ICU	Up to 28 days
Secondary	Infection rate during ICU stay	New diagnosis of infections during the ICU stay	Up to 28 days