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

NCT ID: NCT05726513

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2024-12-31

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 .

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Low support, high Positive end-expiratory pressure

Low support, high Positive end-expiratory pressure

Group Type OTHER

Weaning trial - Low support, high Positive end-expiratory pressure

Intervention Type DIAGNOSTIC_TEST

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

Low support, zero positive end-expiratory pressure

Low support, zero positive end-expiratory pressure

Group Type OTHER

Weaning trial - Low support, zero positive end-expiratory pressure

Intervention Type DIAGNOSTIC_TEST

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

Zero support, zero positive end-expiratory pressure

Zero support, zero positive end-expiratory pressure

Group Type OTHER

Weaning trial - Zero support, zero positive end-expiratory pressure

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role collaborator

Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Savino Spadaro

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Savino Spadaro, MD

Role: primary

+390532239780

Other Identifiers

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WEAN-EIT

Identifier Type: -

Identifier Source: org_study_id

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