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NCT Number: NCT03894332

Lung Impedetiometric Modification in SBT and Extubation Failure

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.

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Key information

Conditions

Weaning Failure Mechanical Ventilation Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical Impedance Tomography (EIT)

Diagnostic Test

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).

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Inhomogeneity Index (GI) at baseline

    Time frame: At baseline during Pressure Support Ventilation

    Inhomogeneity Index (GI) as assessed through electrical impedance tomography

  10. 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

  11. 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

  12. 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

  13. 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

Secondary outcomes

  1. Arterial Blood Gases at baseline

    Time frame: At baseline during Pressure Support Ventilation

    Arterial Blood was sampled for gas analysis

  2. Arterial Blood Gases at SBT_30

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

    Arterial Blood was sampled for gas analysis

  3. Arterial Blood Gases at SB_30

    Time frame: At 30 minutes after extubation (SB_30)

    Arterial Blood was sampled for gas analysis

  4. the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at baseline

    Time frame: At baseline during Pressure Support Ventilation

    the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt)

  5. the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at 5 minutes of Spontaneous Breathing Trial (SBT_0)

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

    the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt)

  6. the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at SBT_30

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

    the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt)

  7. the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at 5 minutes after extubation (SB_0)

    Time frame: At 5 minutes after extubation (SB_0)

    the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt)

  8. the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at 30 minutes after extubation (SB_30)

    Time frame: At 30 minutes after extubation (SB_30)

    the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt)

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

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

Acronym: CPAP2-EIT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 28, 2019
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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