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

Not Applicable

Not yet recruiting

• Conditions: Acute Respiratory Failure; Abdominal Sepsis; Ventilation Therapy; Complications; Emergencies
• Interventions: 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

• Registration Number: NCT05726500
• Lead Sponsor: Università degli Studi di Ferrara

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-13
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-02
• Last Update Submitted: 2023-02-02
• Study First Posted: 2023-02-14
• Last Update Posted: 2023-02-14
• Study Start: 2023-02-15
• Primary Completion: 2024-05-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Abdomen	Esophageal pressure monitoring	-
Closed Abdomen	Esophageal pressure monitoring	-
Closed Abdomen	Arterial blood gas analysis	-
Closed Abdomen	Intrabdominal pressure	-
Closed Abdomen	Venous blood gas analysis	-
Open Abdomen	Arterial blood gas analysis	-
Open Abdomen	Intrabdominal pressure	-
Open Abdomen	Venous blood gas analysis	-
Open Abdomen	Electrical impedance tomopgraphy	-
Closed Abdomen	Electrical impedance tomopgraphy	-

Primary Outcome Measures

Name	Time	Method
Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator	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 Outcome Measures

Name	Time	Method
Infection rate during ICU stay	Up to 28 days	New diagnosis of infections during the ICU stay
Mortality in the intensive care unit	Up to 28 days	Mortality rate in ICU
Regional ventilation distribution measured using Electrical impedance tomography	Day 2	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

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Sant'Anna; 🇮🇹 Ferrara, Italy