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

• Sponsor: Università degli Studi di Ferrara (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05726500
• Collaborator: University of Milan (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22.5
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Sepsis; Acute Respiratory Failure; Ventilation Therapy; Complications; Emergencies	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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of Regional Ventilation Distribution in Patients Affected by Abdominal Sepsis After Emergent Laparotomy
• Anticipated Study Start Date: Feb 15, 2023
• Anticipated Primary Completion Date: May 30, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Open Abdomen	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.; Diagnostic Test: 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.; Diagnostic Test: Esophageal pressure monitoring; The researchers will position an esophageal balloon to evaluate esophageal pressure; Diagnostic Test: Intrabdominal pressure; The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .; Diagnostic Test: Electrical impedance tomopgraphy; The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure
Other: Closed Abdomen	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.; Diagnostic Test: 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.; Diagnostic Test: Esophageal pressure monitoring; The researchers will position an esophageal balloon to evaluate esophageal pressure; Diagnostic Test: Intrabdominal pressure; The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .; Diagnostic Test: Electrical impedance tomopgraphy; The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure

Outcome Measures

Primary Outcome Measures

1. Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator [Day 0]

   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).

2. Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator [Day 1]

   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).

3. 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

1. Regional ventilation distribution measured using Electrical impedance tomography [Day 0]

   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

2. Regional ventilation distribution measured using Electrical impedance tomography [Day 1]

   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

3. 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

4. Mortality in the intensive care unit [Up to 28 days]

   Mortality rate in ICU

5. Infection rate during ICU stay [Up to 28 days]

   New diagnosis of infections during the ICU stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliero Universitaria Sant'Anna	Ferrara		Italy	44121

Sponsors and Collaborators

• Università degli Studi di Ferrara
• University of Milan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Savino Spadaro, Principal investigator, Università degli Studi di Ferrara
• ClinicalTrials.gov Identifier: NCT05726500
• Other Study ID Numbers: CHESTOMY
• First Posted: Feb 14, 2023
• Last Update Posted: Feb 14, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Savino Spadaro, Principal investigator, Università degli Studi di Ferrara: Electrical impedance tomography; Emergent laparotomy; Compliance partinioning
• Additional relevant MeSH terms: Sepsis; Toxemia; Intraabdominal Infections; Respiratory Insufficiency; Emergencies

Study Results

No Results Posted as of Feb 14, 2023