Lung Impedetiometric Modification in SBT and Extubation Failure
NCT ID: NCT03894332
Last Updated: 2019-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2015-06-01
2016-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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SBT Success
Patients took part of this cohort when succeeding the Spontaneous Breathing Trial (SBT).
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).
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:
1. loss of ≥ 2 points of Glasgow Coma Scale
2. respiratory rate/ tidal volume ≥105 breaths/min/L
3. arterial partial pressure of oxygen ≤60 mmHg on inspired oxygen fraction (FiO2) ≥0.5 and/or pH \<7.32 or a decrease in pH ≥0.07 units at the end of the SBT
4. systolic Blood Pressure \<90 mmHg or ≥180 mmHg or increased by ≥20%
5. Heart Rate \>140 beats/min or increased by 20%
6. onset of major heart arrhythmias, or electrocardiographic signs of cardiac ischemia
7. Respiratory Rate ≥35 breaths/min or increased by ≥50%
8. increased effort, respiratory distress (as indicated by diaphoresis, accessory respiratory muscles recruitment, facial signs of distress and/or paradoxical breath)
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).
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.
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).
Extubation Failure
Need for continuous positive airways pressure (CPAP), non invasive ventilation (NIV) or reintubation within 48 hours from extubation, as defined by:
1. Respiratory Rate \>25 breaths/min for 2 hours
2. Heart Rate \>140 beats/min or sustained increase or decrease \>20%
3. clinical signs of respiratory muscle failure
4. arterial partial pressure of oxygen (PaO2) \<80 mmHg on inspired oxygen fraction (FiO2) ≥50%
5. Arterial partial pressure of carbon dioxide \>45 mmHg with pH \<7.33
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* pneumothorax or emphysema
* recent (1 week) thoracic surgery
* presence of chest burns
* pregnancy
* inclusion in other research protocols
18 Years
ALL
No
Sponsors
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University Magna Graecia
OTHER
Responsible Party
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Federico Longhini
Associate Professor
Principal Investigators
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Federico Longhini
Role: PRINCIPAL_INVESTIGATOR
Intensive Care Unit, University Hospital Mater Domini, Department of Medical and Surgical Sciences, Magna Graecia University
References
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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, 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.
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.
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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.
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.
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Other Identifiers
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CPAP2EIT
Identifier Type: -
Identifier Source: org_study_id