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Lung Overdistension and Abdominal Pressure Rise (LOVE BEER)

U

University of Padova

Status

Enrolling

Conditions

Respiratory Failure
Respiratory Distress Syndrome, Adult

Treatments

Procedure: Application of abdominal weight

Study type

Interventional

Funder types

Other

Identifiers

NCT06174636
AOP2978

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Abdominal Pressure Rise
Experimental group
Description:
Application of an abdominal weight and record of respiratory mechanics data, intra-abdominal pressure variation, Electrical Impedance Tomography data
Treatment:
Procedure: Application of abdominal weight

Trial contacts and locations

1

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Central trial contact

Paolo Persona, MD, PhD

Data sourced from clinicaltrials.gov

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