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

NCT05726500 | Unknown

• 1 other identifier: CHESTOMY
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Electrical impedance tomography; Emergent laparotomy; Compliance partinioning

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Regional ventilation distribution measured using Electrical impedance tomography

  Day 0

• Regional ventilation distribution measured using Electrical impedance tomography

  Day 1

• Regional ventilation distribution measured using Electrical impedance tomography

  Day 2

• Mortality in the intensive care unit

  Up to 28 days

• Infection rate during ICU stay

  Up to 28 days

Study Arms (2)

Open Abdomen

OTHER

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

Closed Abdomen

OTHER

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

Interventions

Arterial blood gas analysis DIAGNOSTIC_TEST

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.

Closed Abdomen; Open Abdomen

Venous blood gas analysis DIAGNOSTIC_TEST

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.

Closed Abdomen; Open Abdomen

Esophageal pressure monitoring DIAGNOSTIC_TEST

The researchers will position an esophageal balloon to evaluate esophageal pressure

Closed Abdomen; Open Abdomen

Intrabdominal pressure DIAGNOSTIC_TEST

The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .

Closed Abdomen; Open Abdomen

Electrical impedance tomopgraphy DIAGNOSTIC_TEST

The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure

Closed Abdomen; Open Abdomen

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and \< 90 years
• Admitted to the ICU after emergent laparotomy for abdominal sepsis
• Acute respiratory failure

You may not qualify if:

• Controindications to electrical impedance tomography monitoring
• body mass index \> 40 kg/m2
• Haemodinamic instability
• Pneumothorax - Pneumomediastinum
• refusal to participate

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead
• University of Milan: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, 44121, Italy

Location

MeSH Terms

Conditions

Intraabdominal Infections; Emergencies

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Central Study Contacts

Gaetano Scaramuzzo

CONTACT

0532238108; scrtn@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 14, 2023
• Study Start: February 15, 2023
• Primary Completion: May 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)