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

Study Overview
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Brief Summary
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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 .

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

Conditions
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Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury, Weaning Failure

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low support, high Positive end-expiratory pressure<br>Low support, high Positive end-expiratory pressure | Diagnostic Test: Weaning trial - Low support, high Positive end-expiratory pressure<br>* 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<br>|
| Other: Low support, zero positive end-expiratory pressure<br>Low support, zero positive end-expiratory pressure | Diagnostic Test: Weaning trial - Low support, zero positive end-expiratory pressure<br>* 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<br>|
| Other: Zero support, zero positive end-expiratory pressure<br>Zero support, zero positive end-expiratory pressure | Diagnostic Test: Weaning trial - Zero support, zero positive end-expiratory pressure<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical Impedance tomography, Weaning trial, Acute respiratory failure, Lung monitoring