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Clinical Trials/NCT05726500
NCT05726500
Not yet recruiting
Not Applicable

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

Università degli Studi di Ferrara1 site in 1 country30 target enrollmentFebruary 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Sepsis
Sponsor
Università degli Studi di Ferrara
Enrollment
30
Locations
1
Primary Endpoint
Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2023
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Università degli Studi di Ferrara
Responsible Party
Principal Investigator
Principal Investigator

Savino Spadaro

Principal investigator

Università degli Studi di Ferrara

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

Outcomes

Primary Outcomes

Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator

Time Frame: Day 2

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 Outcomes

  • 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 Sites (1)

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