Lung Impedetiometric Modification in SBT and Extubation Failure

Mechanical Ventilation Complication Clinical Trial

— CPAP2-EIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03894332
• Other study ID #: CPAP2EIT
• Status: Completed
• Start date: June 1, 2015
• Est. completion date: June 30, 2016

Study information

• Verified date: March 2019
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2016
• Est. primary completion date: June 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Weaning Failure

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

References & Publications (15)

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. — View Citation

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. — View Citation

Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. Review. — View Citation

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. Epub 2006 May 31. — View Citation

Ferrer M, Sellarés 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. — View Citation

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. Epub 2005 Oct 13. — View Citation

Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Böhm 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ornico SR, Lobo SM, Sanches HS, Deberaldini M, Tófoli 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. — View Citation

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. — View Citation

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. — View Citation

Zhao Z, Möller 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. — View Citation

Zhao Z, Peng SY, Chang MY, Hsu YL, Frerichs I, Chang HT, Möller 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of end-expiratory lung impedance (dEELI) from baseline at first 5 minute of Spontaneous Breathing Trial (SBT_0)	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)
Primary	Change of end-expiratory lung impedance (dEELI) from baseline at last 5 minute of Spontaneous Breathing Trial (SBT_30)	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)
Primary	Change of end-expiratory lung impedance (dEELI) from baseline at first 5 minute after extubation (SB_0)	change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography	At 5 minutes after extubation
Primary	Change of end-expiratory lung impedance (dEELI) from baseline at last 30 minute after extubation (SB_30)	change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography	At 30 minutes after extubation
Primary	Change of tidal volume in percentage (dVt%) from baseline at last 5 minute of SBT (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)
Primary	Change of tidal volume in percentage (dVt%) from baseline from baseline at 30 minute of Spontaneous Breathing Trial (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)
Primary	Change of tidal volume in percentage (dVt%) from baseline after 5 minutes from 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)
Primary	Change of tidal volume in percentage (dVt%) from baseline at last 30 minute 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)
Primary	Inhomogeneity Index (GI) at baseline	Inhomogeneity Index (GI) as assessed through electrical impedance tomography	At baseline during Pressure Support Ventilation
Primary	Inhomogeneity Index (GI) after 5 minutes of the Spontaneous Breathing Trials (SBT_0)	Inhomogeneity Index (GI) as assessed through electrical impedance tomography	At 5 minutes of Spontaneous Breathing Trial (SBT_0)
Primary	Inhomogeneity Index (GI) after 30 minutes of the Spontaneous Breathing Trials (SBT_30)	Inhomogeneity Index (GI) as assessed through electrical impedance tomography	At 30 minutes of Spontaneous Breathing Trial (SBT_30)
Primary	Inhomogeneity Index (GI) after 5 minutes from extubation (SB_0)	Inhomogeneity Index (GI) as assessed through electrical impedance tomography	At 5 minutes after extubation (SB_0)
Primary	Inhomogeneity Index (GI) after 30 minutes from extubation (SB_30)	Inhomogeneity Index (GI) as assessed through electrical impedance tomography	At 30 minutes after extubation (SB_30)
Secondary	Arterial Blood Gases at baseline	Arterial Blood was sampled for gas analysis	At baseline during Pressure Support Ventilation
Secondary	Arterial Blood Gases at SBT_30	Arterial Blood was sampled for gas analysis	At 30 minutes of Spontaneous Breathing Trial (SBT_30)
Secondary	Arterial Blood Gases at SB_30	Arterial Blood was sampled for gas analysis	At 30 minutes after extubation (SB_30)
Secondary	the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at baseline	the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt)	At baseline during Pressure Support Ventilation
Secondary	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 5 minutes of Spontaneous Breathing Trial (SBT_0)
Secondary	the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) at SBT_30	the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt)	At 30 minutes of Spontaneous Breathing Trial (SBT_30)
Secondary	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 5 minutes after extubation (SB_0)
Secondary	the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt) 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)