- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06174636
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
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
- Name: Paolo Persona, MD, PhD
- Phone Number: +39 3389745902
- Email: ppersona75@gmail.com
Study Locations
-
-
-
Padova, Italy, 35100
- Recruiting
- Azienda Ospedaliera Universita di Padova
-
Contact:
- Paolo Persona, MD
- Phone Number: 00390498212222
- Email: ppersona75@gmail.com
-
-
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
|
Application of variable weight on the abdomen to reach a 5 mmHg increase in IAP
Other Names:
|
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
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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