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Clinical Trials/NCT03894332
NCT03894332
Completed
Not Applicable

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

University Magna Graecia0 sites80 target enrollmentJune 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Weaning Failure
Sponsor
University Magna Graecia
Enrollment
80
Primary Endpoint
Change of tidal volume in percentage (dVt%) from baseline after 5 minutes from extubation (SB_0)
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 1, 2015
End Date
June 30, 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Magna Graecia
Responsible Party
Principal Investigator
Principal Investigator

Federico Longhini

Associate Professor

University Magna Graecia

Eligibility Criteria

Inclusion Criteria

  • Glasgow Coma Scale ≥8
  • presence of clearly audible cough during suctioning with need for tracheal suctioning ≤2/hour
  • normal sodium blood values
  • core temperature \<38.5° during the previous 8 hours
  • Arterial partial pressure of oxygen to inspired oxygen fraction (PaO2/FiO2) ≥200 mmHg, with a Positive End Expiratory Pressure ≤5 cmH2O and FiO2 ≤0.4
  • stable cardiovascular status (i.e., HR ≤140 beats/min, sBP between 90 and 160 mmHg without need for vasopressin, epinephrine or norepinephrine infusion, or with dopamine or dobutamine infusion ≤5 mcg/kg/min)
  • cuff leak volume \>110 mL

Exclusion Criteria

  • major heart arrhythmias or cardiac ischemia
  • pneumothorax or emphysema
  • recent (1 week) thoracic surgery
  • presence of chest burns
  • pregnancy
  • inclusion in other research protocols

Outcomes

Primary Outcomes

Change of tidal volume in percentage (dVt%) from baseline after 5 minutes from extubation (SB_0)

Time Frame: At 5 minutes after extubation (SB_0)

change from baseline, expressed in percentage, of the end expiratory lung volume as assessed through electrical impedance tomography

Inhomogeneity Index (GI) at baseline

Time Frame: At baseline during Pressure Support Ventilation

Inhomogeneity Index (GI) as assessed through electrical impedance tomography

Change of end-expiratory lung impedance (dEELI) from baseline at first 5 minute of Spontaneous Breathing Trial (SBT_0)

Time Frame: At 5 minutes of Spontaneous Breathing Trial (SBT)

change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography

Change of end-expiratory lung impedance (dEELI) from baseline at last 30 minute after extubation (SB_30)

Time Frame: At 30 minutes after extubation

change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography

Change of tidal volume in percentage (dVt%) from baseline at last 5 minute of SBT (SBT_0)

Time Frame: At 5 minutes of spontaneous breathing trial (SBT_0)

change from baseline, expressed in percentage, of the end expiratory lung volume as assessed through electrical impedance tomography

Change of tidal volume in percentage (dVt%) from baseline from baseline at 30 minute of Spontaneous Breathing Trial (SBT_30)

Time Frame: At the last 5 minutes of Spontaneous Breathing Trial (SBT) (SBT_30)

change from baseline, expressed in percentage, of the end expiratory lung volume as assessed through electrical impedance tomography

Change of tidal volume in percentage (dVt%) from baseline at last 30 minute after extubation (SB_30)

Time Frame: At 30 minutes after extubation (SB_30)

change from baseline, expressed in percentage, of the end expiratory lung volume as assessed through electrical impedance tomography

Inhomogeneity Index (GI) after 30 minutes of the Spontaneous Breathing Trials (SBT_30)

Time Frame: At 30 minutes of Spontaneous Breathing Trial (SBT_30)

Inhomogeneity Index (GI) as assessed through electrical impedance tomography

Inhomogeneity Index (GI) after 30 minutes from extubation (SB_30)

Time Frame: At 30 minutes after extubation (SB_30)

Inhomogeneity Index (GI) as assessed through electrical impedance tomography

Change of end-expiratory lung impedance (dEELI) from baseline at last 5 minute of Spontaneous Breathing Trial (SBT_30)

Time Frame: At the last 5 minutes of Spontaneous Breathing Trial (SBT)

change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography

Change of end-expiratory lung impedance (dEELI) from baseline at first 5 minute after extubation (SB_0)

Time Frame: At 5 minutes after extubation

change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography

Inhomogeneity Index (GI) after 5 minutes of the Spontaneous Breathing Trials (SBT_0)

Time Frame: At 5 minutes of Spontaneous Breathing Trial (SBT_0)

Inhomogeneity Index (GI) as assessed through electrical impedance tomography

Inhomogeneity Index (GI) after 5 minutes from extubation (SB_0)

Time Frame: At 5 minutes after extubation (SB_0)

Inhomogeneity Index (GI) as assessed through electrical impedance tomography

Secondary Outcomes

  • the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at 5 minutes after extubation (SB_0)(At 5 minutes after extubation (SB_0))
  • the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at 30 minutes after extubation (SB_30)(At 30 minutes after extubation (SB_30))
  • Arterial Blood Gases at baseline(At baseline during Pressure Support Ventilation)
  • Arterial Blood Gases at SBT_30(At 30 minutes of Spontaneous Breathing Trial (SBT_30))
  • Arterial Blood Gases at SB_30(At 30 minutes after extubation (SB_30))
  • the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at baseline(At baseline during Pressure Support Ventilation)
  • the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at SBT_30(At 30 minutes of Spontaneous Breathing Trial (SBT_30))
  • the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at 5 minutes of Spontaneous Breathing Trial (SBT_0)(At 5 minutes of Spontaneous Breathing Trial (SBT_0))

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