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

Primary Purpose

Abdominal Sepsis, Acute Respiratory Failure, Ventilation Therapy; Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Arterial blood gas analysis
Venous blood gas analysis
Esophageal pressure monitoring
Intrabdominal pressure
Electrical impedance tomopgraphy
Sponsored by
Università degli Studi di Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Sepsis focused on measuring Electrical impedance tomography, Emergent laparotomy, Compliance partinioning

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Ospedaliero Universitaria Sant'Anna

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Open Abdomen

Closed Abdomen

Arm Description

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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
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
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
Mortality in the intensive care unit
Mortality rate in ICU
Infection rate during ICU stay
New diagnosis of infections during the ICU stay

Full Information

First Posted
January 13, 2023
Last Updated
February 2, 2023
Sponsor
Università degli Studi di Ferrara
Collaborators
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT05726500
Brief Title
Evaluation of Regional Ventilation Distribution in Patients Affected by Abdominal Sepsis After Emergent Laparotomy
Acronym
CHESTOMY
Official Title
Evaluation of Regional Ventilation Distribution in Patients Affected by Abdominal Sepsis After Emergent Laparotomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 15, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Ferrara
Collaborators
University of Milan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Sepsis, Acute Respiratory Failure, Ventilation Therapy; Complications, Emergencies
Keywords
Electrical impedance tomography, Emergent laparotomy, Compliance partinioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Abdomen
Arm Type
Other
Arm Title
Closed Abdomen
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Arterial blood gas analysis
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Venous blood gas analysis
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Esophageal pressure monitoring
Intervention Description
The researchers will position an esophageal balloon to evaluate esophageal pressure
Intervention Type
Diagnostic Test
Intervention Name(s)
Intrabdominal pressure
Intervention Description
The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .
Intervention Type
Diagnostic Test
Intervention Name(s)
Electrical impedance tomopgraphy
Intervention Description
The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure
Primary Outcome Measure Information:
Title
Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator
Description
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).
Time Frame
Day 0
Title
Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator
Description
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).
Time Frame
Day 1
Title
Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator
Description
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).
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Regional ventilation distribution measured using Electrical impedance tomography
Description
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
Time Frame
Day 0
Title
Regional ventilation distribution measured using Electrical impedance tomography
Description
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
Time Frame
Day 1
Title
Regional ventilation distribution measured using Electrical impedance tomography
Description
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
Time Frame
Day 2
Title
Mortality in the intensive care unit
Description
Mortality rate in ICU
Time Frame
Up to 28 days
Title
Infection rate during ICU stay
Description
New diagnosis of infections during the ICU stay
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaetano Scaramuzzo
Phone
0532238108
Ext
+39
Email
scrtn@unife.it
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria Sant'Anna
City
Ferrara
ZIP/Postal Code
44121
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savino Spadaro, MD
Phone
+390532239780
Email
savinospadaro@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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