Evaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation (WEAN-EIT)

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 .

Study Overview

• Status: Recruiting
• Conditions: Ventilator-Induced Lung Injury; Mechanical Ventilation Complication; Weaning Failure; Acute Respiratory Failure
• Intervention / Treatment: Diagnostic test: Weaning trial - Low support, high Positive end-expiratory pressure; Diagnostic test: Weaning trial - Low support, zero positive end-expiratory pressure; Diagnostic test: Weaning trial - Zero support, zero positive end-expiratory pressure

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44121
    • Recruiting
    • Azienda Ospedaliero Universitaria Sant'Anna
    • Sub-Investigator: Gaetano Scaramuzzo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Low support, high Positive end-expiratory pressure	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
OTHER: Low support, zero positive end-expiratory pressure	Diagnostic test: 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
OTHER: Zero support, zero positive end-expiratory pressure	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara
• Collaborators: University of Milan

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 15, 2023
• Primary Completion (ANTICIPATED): May 30, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (ESTIMATE): February 14, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Acute respiratory failure; Electrical Impedance tomography; Weaning trial; Lung monitoring
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Respiratory Insufficiency; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: WEAN-EIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No