- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03894332
Lung Impedetiometric Modification in SBT and Extubation Failure (CPAP2-EIT)
Electrical Impedance Tomography During Spontaneous Breathing Trial and Extubation Failure in Critically Ill Patients: an Observational Study
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
SBT Success
Patients took part of this cohort when succeeding the Spontaneous Breathing Trial (SBT).
|
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). |
SBT Failure
Patients took part of this cohort when failing the Spontaneous Breathing Trial (SBT). SBT Failure is defined by one or more of the following criteria occurring during the SBT:
|
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). |
Extubation Success
Patients took part of this cohort when, after extubation, did not need continuous positive airways pressure (CPAP), non invasive ventilation (NIV) or reintubation within 48 hours.
|
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). |
Extubation Failure
Need for continuous positive airways pressure (CPAP), non invasive ventilation (NIV) or reintubation within 48 hours from extubation, as defined by:
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At 5 minutes of Spontaneous Breathing Trial (SBT)
|
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
|
At the last 5 minutes of Spontaneous Breathing Trial (SBT)
|
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
|
At 5 minutes after extubation
|
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
|
At 30 minutes after extubation
|
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
|
At 5 minutes of spontaneous breathing trial (SBT_0)
|
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
|
At the last 5 minutes of Spontaneous Breathing Trial (SBT) (SBT_30)
|
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
|
At 5 minutes after extubation (SB_0)
|
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
|
At 30 minutes after extubation (SB_30)
|
Inhomogeneity Index (GI) at baseline
Time Frame: At baseline during Pressure Support Ventilation
|
Inhomogeneity Index (GI) as assessed through electrical impedance tomography
|
At baseline during Pressure Support Ventilation
|
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
|
At 5 minutes of Spontaneous Breathing Trial (SBT_0)
|
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
|
At 30 minutes of Spontaneous Breathing Trial (SBT_30)
|
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
|
At 5 minutes after extubation (SB_0)
|
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
|
At 30 minutes after extubation (SB_30)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial Blood Gases at baseline
Time Frame: At baseline during Pressure Support Ventilation
|
Arterial Blood was sampled for gas analysis
|
At baseline during Pressure Support Ventilation
|
Arterial Blood Gases at SBT_30
Time Frame: At 30 minutes of Spontaneous Breathing Trial (SBT_30)
|
Arterial Blood was sampled for gas analysis
|
At 30 minutes of Spontaneous Breathing Trial (SBT_30)
|
Arterial Blood Gases at SB_30
Time Frame: At 30 minutes after extubation (SB_30)
|
Arterial Blood was sampled for gas analysis
|
At 30 minutes after extubation (SB_30)
|
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)
|
At baseline during Pressure Support Ventilation
|
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)
|
At 5 minutes of Spontaneous Breathing Trial (SBT_0)
|
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)
|
At 30 minutes of Spontaneous Breathing Trial (SBT_30)
|
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)
|
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)
Time Frame: At 30 minutes after extubation (SB_30)
|
the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt)
|
At 30 minutes after extubation (SB_30)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Federico Longhini, Intensive Care Unit, University Hospital Mater Domini, Department of Medical and Surgical Sciences, Magna Graecia University
Publications and helpful links
General Publications
- Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
- Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
- Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
- Yang KL, Tobin MJ. A prospective study of indexes predicting the outcome of trials of weaning from mechanical ventilation. N Engl J Med. 1991 May 23;324(21):1445-50. doi: 10.1056/NEJM199105233242101.
- Ferrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.
- Nava S, Gregoretti C, Fanfulla F, Squadrone E, Grassi M, Carlucci A, Beltrame F, Navalesi P. Noninvasive ventilation to prevent respiratory failure after extubation in high-risk patients. Crit Care Med. 2005 Nov;33(11):2465-70. doi: 10.1097/01.ccm.0000186416.44752.72.
- Ferrer M, Valencia M, Nicolas JM, Bernadich O, Badia JR, Torres A. Early noninvasive ventilation averts extubation failure in patients at risk: a randomized trial. Am J Respir Crit Care Med. 2006 Jan 15;173(2):164-70. doi: 10.1164/rccm.200505-718OC. Epub 2005 Oct 13.
- El-Solh AA, Aquilina A, Pineda L, Dhanvantri V, Grant B, Bouquin P. Noninvasive ventilation for prevention of post-extubation respiratory failure in obese patients. Eur Respir J. 2006 Sep;28(3):588-95. doi: 10.1183/09031936.06.00150705. Epub 2006 May 31.
- Vianello A, Arcaro G, Braccioni F, Gallan F, Marchi MR, Chizio S, Zampieri D, Pegoraro E, Salvador V. Prevention of extubation failure in high-risk patients with neuromuscular disease. J Crit Care. 2011 Oct;26(5):517-524. doi: 10.1016/j.jcrc.2010.12.008. Epub 2011 Jan 26.
- Ornico SR, Lobo SM, Sanches HS, Deberaldini M, Tofoli LT, Vidal AM, Schettino GP, Amato MB, Carvalho CR, Barbas CS. Noninvasive ventilation immediately after extubation improves weaning outcome after acute respiratory failure: a randomized controlled trial. Crit Care. 2013 Mar 4;17(2):R39. doi: 10.1186/cc12549.
- Meade M, Guyatt G, Cook D, Griffith L, Sinuff T, Kergl C, Mancebo J, Esteban A, Epstein S. Predicting success in weaning from mechanical ventilation. Chest. 2001 Dec;120(6 Suppl):400S-24S. doi: 10.1378/chest.120.6_suppl.400s.
- Zhao Z, Peng SY, Chang MY, Hsu YL, Frerichs I, Chang HT, Moller K. Spontaneous breathing trials after prolonged mechanical ventilation monitored by electrical impedance tomography: an observational study. Acta Anaesthesiol Scand. 2017 Oct;61(9):1166-1175. doi: 10.1111/aas.12959. Epub 2017 Aug 17.
- Bickenbach J, Czaplik M, Polier M, Marx G, Marx N, Dreher M. Electrical impedance tomography for predicting failure of spontaneous breathing trials in patients with prolonged weaning. Crit Care. 2017 Jul 12;21(1):177. doi: 10.1186/s13054-017-1758-2.
- Navalesi P, Frigerio P, Moretti MP, Sommariva M, Vesconi S, Baiardi P, Levati A. Rate of reintubation in mechanically ventilated neurosurgical and neurologic patients: evaluation of a systematic approach to weaning and extubation. Crit Care Med. 2008 Nov;36(11):2986-92. doi: 10.1097/CCM.0b013e31818b35f2.
- Zhao Z, Moller K, Steinmann D, Frerichs I, Guttmann J. Evaluation of an electrical impedance tomography-based Global Inhomogeneity Index for pulmonary ventilation distribution. Intensive Care Med. 2009 Nov;35(11):1900-6. doi: 10.1007/s00134-009-1589-y. Epub 2009 Aug 4.
- Longhini F, Maugeri J, Andreoni C, Ronco C, Bruni A, Garofalo E, Pelaia C, Cavicchi C, Pintaudi S, Navalesi P. Electrical impedance tomography during spontaneous breathing trials and after extubation in critically ill patients at high risk for extubation failure: a multicenter observational study. Ann Intensive Care. 2019 Aug 13;9(1):88. doi: 10.1186/s13613-019-0565-0.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CPAP2EIT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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