CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Electrical Impedance Tomography (EIT)other
Likely dose
Not stated in record
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Search/NCT03894332
NCT03894332N/ACompleted

Electrical Impedance Tomography During Spontaneous Breathing Trial and Extubation Failure in Critically Ill Patients: an Observational Study

University Magna Graecia·observational·Posted Mar 28, 2019·Updated Mar 29, 2019

In Brief

An observational study evaluating Electrical Impedance Tomography (EIT) for Weaning Failure and Mechanical Ventilation Complication. Completed, enrolled 80 participants.

Detailed Summary

Weaning is the entire process aimed at liberating patients from mechanical ventilation and endotracheal intubation. Weaning should be considered as early as possible in order to reduce the time spent in invasive mechanical ventilation (iMV), which is associated with morbidity and mortality. To verify if patients are ready to be extubated, a spontaneous breathing trial (SBT) is performed. At this stage some clinical indices and objective parameters are evaluated, such as the breathing pattern, gas exchange, haemodynamic stability and patient's comfort. In case of SBT success, the patient can be extubated. However, a post-extubation respiratory failure can occur within the first 48 hours after extubation, thus making extubation unsuccessful. Some patients considered at risk for post-extubation respiratory failure benefit from the application of non-invasive ventilation (NIV) after extubation. Early characterization of these patients is crucial to improve their clinical outcomes. Electrical Impedance Tomography (EIT) has been introduced in clinical practice as a non-invasive bedside monitoring tool to evaluate the aeration and ventilation of different lung regions. EIT has been proposed to guide ventilator settings adjustments in critically ill patients and to monitor prolonged weaning. However, the potential of EIT to assess SBT and after extubation in a general ICU population has never been evaluated insofar. The present study aims to describe the modifications of lung aeration, ventilation and inhomogeneity occurring during SBT and after extubation in a general population of critically ill patients at the first SBT attempt.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 28, 2019
Enrollment StartJun 1, 2015
Primary CompletionJun 27, 2016
Study CompletionJun 30, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.3 years ago

Interventions

Electrical Impedance Tomography (EIT)other

After enrollment, a silicon EIT belt of proper size with 16 electrodes was placed around the patient's chest between the 4th and 6th intercostal spaces, and connected to the EIT device. All patients were ventilated in Pressure Support Ventilation (PSV) mode, with a dedicated ventilator connected to the EIT device. We acquired 5-min EIT data records at baseline (during PSV), during the first (SBT\_0) and the last (SBT\_30) 5 minutes of SBT, and, when the patient was extubated, during spontaneous breathing soon after (SB\_0) and 30 minutes after extubation (SB\_30). EIT and ventilator data were recorded at a sample of 20 Hz. The last 3 minutes of each record were analyzed. We measured respiratory rate (RR); Vt changes from baseline, expressed as percent (dVt%); dEELI variations from baseline, expressed in mL; the Global Inhomogeneity index (GI); Impedance ratio (IR) and the Center of Ventilation (CoV).