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Clinical Trials/NCT05726513
NCT05726513
Recruiting
Not Applicable

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

Università degli Studi di Ferrara1 site in 1 country30 target enrollmentFebruary 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Failure
Sponsor
Università degli Studi di Ferrara
Enrollment
30
Locations
1
Primary Endpoint
Regional Ventilation distribution using Electrical Impedance Tomography
Status
Recruiting
Last Updated
3 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
February 15, 2023
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Università degli Studi di Ferrara
Responsible Party
Principal Investigator
Principal Investigator

Savino Spadaro

Principal investigator

Università degli Studi di Ferrara

Eligibility Criteria

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

Outcomes

Primary Outcomes

Regional Ventilation distribution using Electrical Impedance Tomography

Time Frame: 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 Outcomes

  • Differences in Regional Ventilation distribution using Electrical Impedance Tomography between weaning trials and post-extubation phase(48 hours)

Study Sites (1)

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