Lung Overdistension and Abdominal Pressure Rise

Respiratory Failure Clinical Trial

— LOVE BEER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174636
• Other study ID #: AOP2978
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: University of Padova
• Contact: Paolo Persona, MD, PhD
• Phone: +39 3389745902
• Email: ppersona75[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• Application of abdominal weight
Application of variable weight on the abdomen to reach a 5 mmHg increase in IAP

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Università di Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of lung volume distribution	TID %	through study completion, an average of 1 year
Primary	Variation of airway pressure	cmH2O	through study completion, an average of 1 year
Primary	Variation of esophageal pressure	cmH2O	through study completion, an average of 1 year