Lung Overdistension and Abdominal Pressure Rise
LOVE BEER
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2023
CompletedFirst Submitted
Initial submission to the registry
July 9, 2023
CompletedFirst Posted
Study publicly available on registry
December 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedDecember 18, 2023
December 1, 2023
2 years
July 9, 2023
December 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Variation of lung volume distribution
TID %
through study completion, an average of 1 year
Variation of airway pressure
cmH2O
through study completion, an average of 1 year
Variation of esophageal pressure
cmH2O
through study completion, an average of 1 year
Study Arms (1)
Abdominal Pressure Rise
EXPERIMENTALApplication of an abdominal weight and record of respiratory mechanics data, intra-abdominal pressure variation, Electrical Impedance Tomography data
Interventions
Application of variable weight on the abdomen to reach a 5 mmHg increase in IAP
Eligibility Criteria
You may qualify if:
- Invasive mechanical ventilation in acute respiratory failure (PaO2/FiO2 \<300 mmHg)
- Need of PEEP trial
- Need of urinary catheter (used to measure IAP)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedaliera Università di Padova
Padua, 35100, Italy
Related Publications (1)
Pacchiarini G, Pettenuzzo T, Zarantonello F, Sella N, Lumetti G, Boscolo A, De Cassai A, Cammarota G, Persona P, Navalesi P; LOVE BEER Study Group. The "mechanical paradox" unveiled: a physiological study. Crit Care. 2025 May 16;29(1):194. doi: 10.1186/s13054-025-05385-9.
PMID: 40380228DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, Principal Investigator
Study Record Dates
First Submitted
July 9, 2023
First Posted
December 18, 2023
Study Start
June 20, 2023
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
December 18, 2023
Record last verified: 2023-12