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

Acute Respiratory Failure Clinical Trial

— WEAN-EIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726513
• Other study ID #: WEAN-EIT
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Lung Injury
• Mechanical Ventilation Complication
• Respiratory Insufficiency
• Ventilator-Induced Lung Injury
• Weaning Failure

Intervention

Diagnostic Test:
• Weaning trial - Low support, high Positive end-expiratory pressure
The researcher will evaluate the readiness to be weaned of the patient using a weaning trial with low pressure support ventilation and a positive end expiratory pressure of 5 cmH2O
• Weaning trial - Low support, zero positive end-expiratory pressure
The researcher will evaluate the readiness to be weaned of the patient using a weaning trial with low pressure support ventilation and a positive end expiratory pressure of 0 cmH2O
• Weaning trial - Zero support, zero positive end-expiratory pressure
The researcher will evaluate the readiness to be weaned of the patient using a weaning trial with 0 pressure support ventilation and a positive end expiratory pressure of 0 cmH2O

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Sant'Anna	Ferrara

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara	University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional Ventilation distribution using Electrical Impedance Tomography	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	2 hours
Secondary	Differences in Regional Ventilation distribution using Electrical Impedance Tomography between weaning trials and post-extubation phase	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	48 hours