Evaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation

Not Applicable

Recruiting

• Conditions: Weaning Failure; Acute Respiratory Failure; Ventilator-Induced Lung Injury; Mechanical Ventilation Complication
• Interventions: Diagnostic Test: Weaning trial - Low support, high Positive end-expiratory pressure; Diagnostic Test: Weaning trial - Zero support, zero positive end-expiratory pressure; Diagnostic Test: Weaning trial - Low support, zero positive end-expiratory pressure

• Registration Number: NCT05726513
• Lead Sponsor: Università degli Studi di Ferrara

Brief Summary

The goal of this physiological cross-over clinical trial is to evaluate the effect of different clinically used weaning trials on regional mechanical ventilation in a population of patients undergoing weaning from mechanical ventilation for acute respiratory failure.

The main question\[s\] it aims to answer are:

* to evaluate which weaning trial is associated to a better regional ventilation distribution

* to evaluate which weaning trial can be comparable to ventilation distribution after extubation

Participants will undergo 3 clinically used weaning trials in a random order (cross-over trial). Researchers will compare the different steps to see if regional ventilation distribution is different among the different trial .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-13
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-02
• Last Update Submitted: 2023-02-02
• Study First Posted: 2023-02-14
• Last Update Posted: 2023-02-14
• Study Start: 2023-02-15
• Primary Completion: 2024-05-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age > 18 and < 70 years
• Ready to be weaned from mechanical ventilation according to clinical criteria

Exclusion Criteria

• Age < 18 years or > 70 years
• Presence of chest drains
• Presence of pacemaker/impantable cardiac device;
• diagnosis of Pneumothorax, or pneumomediastinum
• Diagnois of neuromuscular diseases
• Use of neuromuscular blockers in the 48 hours before screening;
• Body mass index > 35 kg/m2
• Refusal to participate of the patient/next of kin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low support, high Positive end-expiratory pressure	Weaning trial - Low support, high Positive end-expiratory pressure	Low support, high Positive end-expiratory pressure
Zero support, zero positive end-expiratory pressure	Weaning trial - Zero support, zero positive end-expiratory pressure	Zero support, zero positive end-expiratory pressure
Low support, zero positive end-expiratory pressure	Weaning trial - Low support, zero positive end-expiratory pressure	Low support, zero positive end-expiratory pressure

Primary Outcome Measures

Name	Time	Method
Regional Ventilation distribution using Electrical Impedance Tomography	2 hours	The researchers will evaluate differences in ventilation distribution pattern among the different weaning trials using Electrical Impedance Tomography and focusing on: * Regional ventilation distribution; * Regional inhomogeneity; * Regional compliance distribution; * Center of Ventilation; * Silent Spaces

Secondary Outcome Measures

Name	Time	Method
Differences in Regional Ventilation distribution using Electrical Impedance Tomography between weaning trials and post-extubation phase	48 hours	The researchers will evaluate differences in ventilation distribution pattern among the different weaning trials and the post-extubation phase using Electrical Impedance Tomography and focusing on: * Regional ventilation distribution; * Regional inhomogeneity; * Regional compliance distribution; * Center of Ventilation; * Silent Spaces

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Sant'Anna; 🇮🇹 Ferrara, Italy