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

U

Università degli Studi di Ferrara

Status

Enrolling

Conditions

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

Treatments

Diagnostic Test: Weaning trial - Low support, zero positive end-expiratory pressure
Diagnostic Test: Weaning trial - Zero support, zero positive end-expiratory pressure
Diagnostic Test: Weaning trial - Low support, high Positive end-expiratory pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT05726513
WEAN-EIT

Details and patient eligibility

About

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 .

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

30 participants in 3 patient groups

Low support, high Positive end-expiratory pressure
Other group
Description:
Low support, high Positive end-expiratory pressure
Treatment:
Diagnostic Test: Weaning trial - Low support, high Positive end-expiratory pressure
Low support, zero positive end-expiratory pressure
Other group
Description:
Low support, zero positive end-expiratory pressure
Treatment:
Diagnostic Test: Weaning trial - Low support, zero positive end-expiratory pressure
Zero support, zero positive end-expiratory pressure
Other group
Description:
Zero support, zero positive end-expiratory pressure
Treatment:
Diagnostic Test: Weaning trial - Zero support, zero positive end-expiratory pressure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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