Weaning FailureCPAP2-EITNCT03894332

Lung Impedetiometric Modification in SBT and Extubation Failure

An observational study of Weaning Failure and Mechanical Ventilation Complication, run by University Magna Graecia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Weaning Failure, Mechanical Ventilation Complication
What is being tested?: Electrical Impedance Tomography (EIT)
How many people: 80 participants
Where: No sites listed yet
Study dates: 1 Jun 2015to 30 Jun 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

major heart arrhythmias or cardiac ischemia
pneumothorax or emphysema
recent (1 week) thoracic surgery
presence of chest burns
pregnancy

About this study

Official title: 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.

Conditions: Weaning Failure, Mechanical Ventilation Complication
Being tested: Electrical Impedance Tomography (EIT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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).

Study groups in NCT03894332
Study group	Role	What they receive
SBT Success		Patients took part of this cohort when succeeding the Spontaneous Breathing Trial (SBT). Receives: Diagnostic Test: Electrical Impedance Tomography (EIT)
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) Receives: Diagnostic Test: Electrical Impedance Tomography (EIT)
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. Receives: Diagnostic Test: Electrical Impedance Tomography (EIT)
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 Receives: Diagnostic Test: Electrical Impedance Tomography (EIT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Measured: 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)
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Measured: At 5 minutes after extubation
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
Measured: At 30 minutes after extubation
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
Measured: 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)
change from baseline, expressed in percentage, of the end expiratory lung volume as assessed through electrical impedance tomography
Measured: 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)
change from baseline, expressed in percentage, of the end expiratory lung volume as assessed through electrical impedance tomography
Measured: At 5 minutes after extubation (SB_0)
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
Measured: At 30 minutes after extubation (SB_30)
Inhomogeneity Index (GI) at baseline
Inhomogeneity Index (GI) as assessed through electrical impedance tomography
Measured: At baseline during Pressure Support Ventilation
Inhomogeneity Index (GI) after 5 minutes of the Spontaneous Breathing Trials (SBT_0)
Inhomogeneity Index (GI) as assessed through electrical impedance tomography
Measured: At 5 minutes of Spontaneous Breathing Trial (SBT_0)
Inhomogeneity Index (GI) after 30 minutes of the Spontaneous Breathing Trials (SBT_30)
Inhomogeneity Index (GI) as assessed through electrical impedance tomography
Measured: At 30 minutes of Spontaneous Breathing Trial (SBT_30)
Inhomogeneity Index (GI) after 5 minutes from extubation (SB_0)
Inhomogeneity Index (GI) as assessed through electrical impedance tomography
Measured: At 5 minutes after extubation (SB_0)
Inhomogeneity Index (GI) after 30 minutes from extubation (SB_30)
Inhomogeneity Index (GI) as assessed through electrical impedance tomography
Measured: At 30 minutes after extubation (SB_30)

Secondary outcomes (8)

Arterial Blood Gases at baseline
Arterial Blood was sampled for gas analysis
Measured: At baseline during Pressure Support Ventilation
Arterial Blood Gases at SBT_30
Arterial Blood was sampled for gas analysis
Measured: At 30 minutes of Spontaneous Breathing Trial (SBT_30)
Arterial Blood Gases at SB_30
Arterial Blood was sampled for gas analysis
Measured: At 30 minutes after extubation (SB_30)
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)
Measured: 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)
the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt)
Measured: At 5 minutes of Spontaneous Breathing Trial (SBT_0)
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)
Measured: 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)
the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt)
Measured: 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)
the ratio between respiratory rate (RR) and tidal volume (Vt) (RR/Vt)
Measured: At 30 minutes after extubation (SB_30)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201530 Jun 2016

First posted28 Mar 2019
Study start1 Jun 2015
Primary completion27 Jun 2016
Study completion30 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Weaning FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03894332
Sponsor's protocol ID: CPAP2EIT
Acronym: CPAP2-EIT
Status last verified: Mar 2019
First submitted: 10 Feb 2019
Last updated: 29 Mar 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: The full protocol, datasets used and analysed during the current study are available on reasonable request at longhini.federico@gmail.com.

Publications

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.
PubMed 17470624
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.
PubMed 16276167
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.
PubMed 19682735
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.
PubMed 16224108
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.
PubMed 16737982
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.
PubMed 21273033
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.
PubMed 23497557
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.
PubMed 11742961
Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
PubMed 19186406
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.
PubMed 27596161
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.
PubMed 28832898
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.
PubMed 28697778
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.
PubMed 18824909
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.
PubMed 2023603
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.
PubMed 19652949

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
Ventilator Induced Diaphragm Dysfunction
Recruiting
Physiological Effect High-flow Tracheal Oxygen on Viscosity of Airway Mucus and Respiratory Effort in Patients Weaning From Invasive Mechanical Ventilation
Weaning From Mechanical Ventilation, Tracheostomy Weaning
Not yet recruiting
Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients
Acute Hypoxemic Respiratory Failure, High-Flow Nasal Cannula Therapy
RecruitingObservational study
Characterization of Weaning Practices in ICUs of Global South Countries
Weaning From Mechanical Ventilation, Weaning Failure
Not yet recruiting
One-Hour Positive Pressure Ventilation After a Pressure Support Spontaneous Breathing Trial
Airway Extubation, Weaning Mechanical Ventilation

All Weaning Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Electrical Impedance Tomography During Spontaneous Breathing Trial and Extubation Failure in Critically Ill Patients: an Observational Study
ClinicalTrials.gov ID: NCT03894332
Acronym / sponsor ID: CPAP2-EIT / CPAP2EIT
Conditions: Weaning Failure, Mechanical Ventilation Complication
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: University Magna GraeciaUniversity, hospital or other
Study start: 1 Jun 2015 (actual)
Primary completion: 27 Jun 2016 (actual)
Study completion: 30 Jun 2016 (actual)
First posted: 28 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
SBT Success	–	Diagnostic Test: Electrical Impedance Tomography (EIT)Patients took part of this cohort when succeeding the Spontaneous Breathing Trial (SBT).
SBT Failure	–	Diagnostic Test: Electrical Impedance Tomography (EIT)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)
Extubation Success	–	Diagnostic Test: Electrical Impedance Tomography (EIT)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.
Extubation Failure	–	Diagnostic Test: Electrical Impedance Tomography (EIT)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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

major heart arrhythmias or cardiac ischemia
pneumothorax or emphysema
recent (1 week) thoracic surgery
presence of chest burns
pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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).	Diagnostic test	Extubation Failure, Extubation Success, SBT Failure, SBT Success

Primary outcome

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
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
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
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
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
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
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
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
Inhomogeneity Index (GI) at baseline
Time frame: At baseline during Pressure Support Ventilation
Inhomogeneity Index (GI) as assessed through electrical impedance tomography
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
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
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
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

8 secondary outcomes

Arterial Blood Gases at baseline
Time frame: 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 Gases at SB_30
Time frame: 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 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 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 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 30 minutes after extubation (SB_30)
Time frame: At 30 minutes after extubation (SB_30)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
Background: PubMed 17470624Boles 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.
Background: PubMed 16276167Nava 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.
Background: PubMed 19682735Ferrer 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.
Background: PubMed 16224108Ferrer 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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Background: PubMed 23497557Ornico 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.
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Background: PubMed 27596161Frerichs 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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Individual participant dataSharing planned: Yes. The full protocol, datasets used and analysed during the current study are available on reasonable request at longhini.federico@gmail.com.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Federico Longhini principal investigator

Intensive Care Unit, University Hospital Mater Domini, Department of Medical and Surgical Sciences, Magna Graecia University

Questions about this trial

What is this clinical trial studying?

An observational study of Weaning Failure and Mechanical Ventilation Complication, run by University Magna Graecia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03894332, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.