Abdominal SepsisCHESTOMYNCT05726500
Evaluation of Regional Ventilation Distribution in Patients Affected by Abdominal Sepsis After Emergent Laparotomy
A study testing Arterial blood gas analysis, Venous blood gas analysis and Esophageal pressure monitoring in people with Abdominal Sepsis and Acute Respiratory Failure, run by Università degli Studi di Ferrara at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Abdominal Sepsis, Acute Respiratory Failure, Ventilation Therapy; Complications
- What is being tested?
- Arterial blood gas analysis, Venous blood gas analysis and Esophageal pressure monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 90 years
- Admitted to the ICU after emergent laparotomy for abdominal sepsis
- Acute respiratory failure
Who cannot join
- Controindications to electrical impedance tomography monitoring
- body mass index > 40 kg/m2
- Haemodinamic instability
- Pneumothorax - Pneumomediastinum
- refusal to participate
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero Universitaria Sant'Anna
Ferrara, 44121
Savino Spadaro, MD, +390532239780, savinospadaro@gmail.com
About this study
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.
- Conditions
- Abdominal Sepsis, Acute Respiratory Failure, Ventilation Therapy; Complications, Emergencies
- Being tested
- Arterial blood gas analysis, Venous blood gas analysis, Esophageal pressure monitoring, Intrabdominal pressure, Electrical impedance tomopgraphy
- Keywords
- Electrical impedance tomography, Emergent laparotomy, Compliance partinioning
- Medical subject headings
- Intraabdominal Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial blood gas analysisDiagnostic test
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 analysisDiagnostic test
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 monitoringDiagnostic test
The researchers will position an esophageal balloon to evaluate esophageal pressure
Intrabdominal pressureDiagnostic test
The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .
Electrical impedance tomopgraphyDiagnostic test
The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure
| Study group | Role | What they receive |
|---|---|---|
| Open Abdomen | Other | Not described Receives: 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 |
| Closed Abdomen | Other | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0
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).
Measured: Day 1
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).
Measured: Day 2
Secondary outcomes (5)
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
Measured: Day 0
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
Measured: Day 1
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
Measured: Day 2
Mortality in the intensive care unit
Mortality rate in ICU
Measured: Up to 28 days
Infection rate during ICU stay
New diagnosis of infections during the ICU stay
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Principal investigator, Savino Spadaro, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726500
- Sponsor's protocol ID
- CHESTOMY
- Acronym
- CHESTOMY
- Status last verified
- Feb 2023
- First submitted
- 13 Jan 2023
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regional Ventilation Distribution in Patients Affected by Abdominal Sepsis After Emergent Laparotomy
- ClinicalTrials.gov ID
- NCT05726500
- Acronym / sponsor ID
- CHESTOMY / CHESTOMY
- Conditions
- Abdominal Sepsis, Acute Respiratory Failure, Ventilation Therapy; Complications, Emergencies
- Keywords
- Electrical impedance tomography, Emergent laparotomy, Compliance partinioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Abdomen | Other | 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 |
| Closed Abdomen | Other | 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 and < 90 years
- Admitted to the ICU after emergent laparotomy for abdominal sepsis
- Acute respiratory failure
Key exclusion criteria (5 listed)
- Controindications to electrical impedance tomography monitoring
- body mass index > 40 kg/m2
- Haemodinamic instability
- Pneumothorax - Pneumomediastinum
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial blood gas analysisThe 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 | Closed Abdomen, Open Abdomen |
| Venous blood gas analysisThe 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 | Closed Abdomen, Open Abdomen |
| Esophageal pressure monitoringThe researchers will position an esophageal balloon to evaluate esophageal pressure | Diagnostic test | Closed Abdomen, Open Abdomen |
| Intrabdominal pressureThe researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes . | Diagnostic test | Closed Abdomen, Open Abdomen |
| Electrical impedance tomopgraphyThe researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure | Diagnostic test | Closed Abdomen, Open Abdomen |
Primary outcome
Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator
Time frame: 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).
Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator
Time frame: 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).
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).
5 secondary outcomes
Regional ventilation distribution measured using Electrical impedance tomography
Time frame: Day 0
Regional ventilation distribution measured using Electrical impedance tomography
Time frame: Day 1
Regional ventilation distribution measured using Electrical impedance tomography
Time frame: Day 2
Mortality in the intensive care unit
Time frame: Up to 28 days
Infection rate during ICU stay
Time frame: Up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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The PASTDUe Nutrition Ecosystem Project (PASTDUe)
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Gelaspan vs Crystalloid Therapy in Sepsis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial blood gas analysis, Venous blood gas analysis and Esophageal pressure monitoring in people with Abdominal Sepsis and Acute Respiratory Failure, run by Università degli Studi di Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaetano Scaramuzzo (0532238108 ext. +39, scrtn@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.