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

NCT ID: NCT05726500

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Abdominal Sepsis Acute Respiratory Failure Ventilation Therapy; Complications Emergencies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Open Abdomen

Group Type OTHER

Arterial blood gas analysis

Intervention Type DIAGNOSTIC_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 analysis

Intervention Type DIAGNOSTIC_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 monitoring

Intervention Type DIAGNOSTIC_TEST

The researchers will position an esophageal balloon to evaluate esophageal pressure

Intrabdominal pressure

Intervention Type DIAGNOSTIC_TEST

The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .

Electrical impedance tomopgraphy

Intervention Type DIAGNOSTIC_TEST

The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure

Closed Abdomen

Group Type OTHER

Arterial blood gas analysis

Intervention Type DIAGNOSTIC_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 analysis

Intervention Type DIAGNOSTIC_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 monitoring

Intervention Type DIAGNOSTIC_TEST

The researchers will position an esophageal balloon to evaluate esophageal pressure

Intrabdominal pressure

Intervention Type DIAGNOSTIC_TEST

The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .

Electrical impedance tomopgraphy

Intervention Type DIAGNOSTIC_TEST

The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Esophageal pressure monitoring

The researchers will position an esophageal balloon to evaluate esophageal pressure

Intervention Type DIAGNOSTIC_TEST

Intrabdominal pressure

The researches will assess intrabdominal pressure using the urinary catheter system already in place for clinical purposes .

Intervention Type DIAGNOSTIC_TEST

Electrical impedance tomopgraphy

The researches will evaluate regional ventilation distribution using Electrical impedance tomography at different levels of positive end-expiratory pressure

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role collaborator

Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Savino Spadaro

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, , Italy

Site Status

Countries

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Italy

Central Contacts

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Gaetano Scaramuzzo

Role: CONTACT

0532238108 ext. +39

Facility Contacts

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Savino Spadaro, MD

Role: primary

+390532239780

Other Identifiers

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CHESTOMY

Identifier Type: -

Identifier Source: org_study_id

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