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

• Sponsor: Università degli Studi di Ferrara (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05726513
• Collaborator: University of Milan (Other)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 22.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure; Mechanical Ventilation Complication; Ventilator-Induced Lung Injury; Weaning Failure	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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation
• Anticipated Study Start Date: Feb 15, 2023
• Anticipated Primary Completion Date: May 30, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Low support, high Positive end-expiratory pressure 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 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 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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliero Universitaria Sant'Anna	Ferrara		Italy	44121

Sponsors and Collaborators

• Università degli Studi di Ferrara
• University of Milan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Savino Spadaro, Principal investigator, Università degli Studi di Ferrara
• ClinicalTrials.gov Identifier: NCT05726513
• Other Study ID Numbers: WEAN-EIT
• First Posted: Feb 14, 2023
• Last Update Posted: Feb 14, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Savino Spadaro, Principal investigator, Università degli Studi di Ferrara: Electrical Impedance tomography; Weaning trial; Acute respiratory failure; Lung monitoring
• Additional relevant MeSH terms: Respiratory Insufficiency; Lung Injury; Ventilator-Induced Lung Injury

Study Results

No Results Posted as of Feb 14, 2023