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Lung Impedetiometric Modification in SBT and Extubation Failure

NCT03894332 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2019-03-29

No results posted yet for this study

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.

Conditions

  • Weaning Failure
  • Mechanical Ventilation Complication

Interventions

DIAGNOSTIC_TEST

Electrical Impedance Tomography (EIT)

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).

Sponsors & Collaborators

  • University Magna Graecia

    lead OTHER

Principal Investigators

  • Federico Longhini · Intensive Care Unit, University Hospital Mater Domini, Department of Medical and Surgical Sciences, Magna Graecia University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2016-06-27
Completion
2016-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03894332 on ClinicalTrials.gov