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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05726500
Other study ID # CHESTOMY
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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