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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Emergencies; Acute Respiratory Failure; Ventilation Therapy; Complications; Abdominal Sepsis
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaetano Scaramuzzo; Phone Number: +39 0532238108; Email: scrtn@unife.it

Study Locations

• Italy
  • Ferrara, Italy, 44121
    • Azienda Ospedaliero Universitaria Sant'Anna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Open Abdomen	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.; Diagnostic test: 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.; Diagnostic test: Esophageal pressure monitoring; The researchers will position an esophageal balloon to evaluate esophageal pressure; Diagnostic test: Intrabdominal pressure; The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .; Diagnostic test: Electrical impedance tomopgraphy; The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure
OTHER: Closed Abdomen	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.; Diagnostic test: 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.; Diagnostic test: Esophageal pressure monitoring; The researchers will position an esophageal balloon to evaluate esophageal pressure; Diagnostic test: Intrabdominal pressure; The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .; Diagnostic test: Electrical impedance tomopgraphy; The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara
• Collaborators: University of Milan

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 15, 2023
• Primary Completion (ANTICIPATED): May 30, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (ESTIMATE): February 14, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Electrical impedance tomography; Emergent laparotomy; Compliance partinioning
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Respiration Disorders; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Emergencies; Respiratory Insufficiency; Intraabdominal Infections
• Other Study ID Numbers: CHESTOMY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No