Lung Overdistension and Abdominal Pressure Rise

Not Applicable

Recruiting

• Conditions: Respiratory Failure; Respiratory Distress Syndrome, Adult
• Interventions: Procedure: Application of abdominal weight

• Registration Number: NCT06174636
• Lead Sponsor: University of Padova

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-20
• Study First Submitted: 2023-07-09
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Study First Posted: 2023-12-18
• Last Update Posted: 2023-12-18
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abdominal Pressure Rise	Application of abdominal weight	Application of an abdominal weight and record of respiratory mechanics data, intra-abdominal pressure variation, Electrical Impedance Tomography data

Primary Outcome Measures

Name	Time	Method
Variation of airway pressure	through study completion, an average of 1 year	cmH2O
Variation of lung volume distribution	through study completion, an average of 1 year	TID %
Variation of esophageal pressure	through study completion, an average of 1 year	cmH2O

Trial Locations

Locations (1)

Azienda Ospedaliera Università di Padova; 🇮🇹 Padova, Italy