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Lung Overdistension and Abdominal Pressure Rise

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06174636
Acronym
LOVE BEER
Enrollment
20
Registered
2023-12-18
Start date
2023-06-20
Completion date
2025-06-30
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Adult, Respiratory Failure

Keywords

Abdominal pressure, Overdistension

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.

Interventions

PROCEDUREApplication of abdominal weight

Application of variable weight on the abdomen to reach a 5 mmHg increase in IAP

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Variation of lung volume distributionthrough study completion, an average of 1 yearTID %
Variation of airway pressurethrough study completion, an average of 1 yearcmH2O
Variation of esophageal pressurethrough study completion, an average of 1 yearcmH2O

Countries

Italy

Contacts

Primary ContactPaolo Persona, MD, PhD
ppersona75@gmail.com+39 3389745902

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026