Lung Overdistension and Abdominal Pressure Rise (LOVE BEER)

December 7, 2023 updated by: Paolo Persona, University of Padova

Lung Overdistension and Abdominal Pressure Rise: an EIT Based Pilot Study

The goal of this pilot interventional no-profit study is to evaluate airway pressure, esophageal pressure and variations in lung volume distribution with EIT in mechanically ventilated patients admitted to our UTI with respiratory failure after the application of an abdominal weight and resulting increase of intra-abdominal pressure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Padova, Italy, 35100
        • Recruiting
        • Azienda Ospedaliera Universita di Padova
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Invasive mechanical ventilation in acute respiratory failure (PaO2/FiO2 <300 mmHg)
  • Need of PEEP trial
  • Need of urinary catheter (used to measure IAP)

Exclusion Criteria:

  • Contraindication to EIT use
  • Pacemaker or other metal device in thoracic region
  • Contraindication to abdominal weight placement
  • Surgical or traumatic incision on the abdomen
  • Severe abdominal hypertension
  • Esophageal diseases that counterindicate naso-gastric tube placement
  • Severe hemodynamic instability (norepinephrine > 0.1 mcg/kg/min; dobutamine or dopamine > 5 mcg/kg/min; epinephrine every dosage)
  • Severe obesity (BMI > 35 kg/m2)
  • Need of > 7 kg weight to reach 5 mmHg IAP increase

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abdominal Pressure Rise
Application of an abdominal weight and record of respiratory mechanics data, intra-abdominal pressure variation, Electrical Impedance Tomography data
Procedure: Application of abdominal weight
Application of variable weight on the abdomen to reach a 5 mmHg increase in IAP
Other Names:
  • Intra abdominal pressure rise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of lung volume distribution
Time Frame: through study completion, an average of 1 year
TID %
through study completion, an average of 1 year
Variation of airway pressure
Time Frame: through study completion, an average of 1 year
cmH2O
through study completion, an average of 1 year
Variation of esophageal pressure
Time Frame: through study completion, an average of 1 year
cmH2O
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

July 9, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOP2978

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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