Clinical trial NCT03894332: Lung Impedetiometric Modification in SBT and Extubation Failure
Official title: Electrical Impedance Tomography During Spontaneous Breathing Trial and Extubation Failure in Critically Ill Patients: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weaning Failure
Mechanical Ventilation Complication
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We considered eligible any critically ill patient ≥18 years receiving invasive Mechanical Ventilation for at least 48 hours through an orotracheal tube, ready for the first Spontaneous Breathing Trial attempt, and met at least one criteria for increased risk of extubation failure.

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.


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

Primary outcomes:
measure: Change of end-expiratory lung impedance (dEELI) from baseline at first 5 minute of Spontaneous Breathing Trial (SBT_0)
timeFrame: At 5 minutes of Spontaneous Breathing Trial (SBT)
measure: Change of end-expiratory lung impedance (dEELI) from baseline at last 5 minute of Spontaneous Breathing Trial (SBT_30)
timeFrame: At the last 5 minutes of Spontaneous Breathing Trial (SBT)
measure: Change of end-expiratory lung impedance (dEELI) from baseline at first 5 minute after extubation (SB_0)
timeFrame: At 5 minutes after extubation
measure: Change of end-expiratory lung impedance (dEELI) from baseline at last 30 minute after extubation (SB_30)
timeFrame: At 30 minutes after extubation
measure: Change of tidal volume in percentage (dVt%) from baseline at last 5 minute of SBT (SBT_0)
timeFrame: At 5 minutes of spontaneous breathing trial (SBT_0)
measure: Change of tidal volume in percentage (dVt%) from baseline from baseline at 30 minute of Spontaneous Breathing Trial (SBT_30)
timeFrame: At the last 5 minutes of Spontaneous Breathing Trial (SBT) (SBT_30)
measure: Change of tidal volume in percentage (dVt%) from baseline after 5 minutes from extubation (SB_0)
timeFrame: At 5 minutes after extubation (SB_0)
measure: Change of tidal volume in percentage (dVt%) from baseline at last 30 minute after extubation (SB_30)
timeFrame: At 30 minutes after extubation (SB_30)
measure: Inhomogeneity Index (GI) at baseline
timeFrame: At baseline during Pressure Support Ventilation
measure: Inhomogeneity Index (GI) after 5 minutes of the Spontaneous Breathing Trials (SBT_0)
timeFrame: At 5 minutes of Spontaneous Breathing Trial (SBT_0)
measure: Inhomogeneity Index (GI) after 30 minutes of the Spontaneous Breathing Trials (SBT_30)
timeFrame: At 30 minutes of Spontaneous Breathing Trial (SBT_30)
measure: Inhomogeneity Index (GI) after 5 minutes from extubation (SB_0)
timeFrame: At 5 minutes after extubation (SB_0)
measure: Inhomogeneity Index (GI) after 30 minutes from extubation (SB_30)
timeFrame: At 30 minutes after extubation (SB_30)
Secondary outcomes:
measure: Arterial Blood Gases at baseline
timeFrame: At baseline during Pressure Support Ventilation
measure: Arterial Blood Gases at SBT_30
timeFrame: At 30 minutes of Spontaneous Breathing Trial (SBT_30)
measure: Arterial Blood Gases at SB_30
timeFrame: At 30 minutes after extubation (SB_30)
measure: the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at baseline
timeFrame: At baseline during Pressure Support Ventilation
measure: the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at 5 minutes of Spontaneous Breathing Trial (SBT_0)
timeFrame: At 5 minutes of Spontaneous Breathing Trial (SBT_0)
measure: the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at SBT_30
timeFrame: At 30 minutes of Spontaneous Breathing Trial (SBT_30)
measure: the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at 5 minutes after extubation (SB_0)
timeFrame: At 5 minutes after extubation (SB_0)
measure: the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at 30 minutes after extubation (SB_30)
timeFrame: At 30 minutes after extubation (SB_30)
Other outcomes:
Locations:
Study officials:
affiliation: Intensive Care Unit, University Hospital Mater Domini, Department of Medical and Surgical Sciences, Magna Graecia University
name: Federico Longhini
role: PRINCIPAL_INVESTIGATOR
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