Study Results
Results pending
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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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-09-15
Study Completion Date
2021-07-15
Brief Summary
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The term ''Non-invasive ventilation'' (NIV) refers to various methods of respiratory assistance, in the absence of an indwelling endotracheal tube. In recent years, the use of NIV has increased for the treatment of both acute and chronic pediatric respiratory failure. Patient tolerance to the technique is a critical factor determining its success in avoiding endotracheal intubation. One of the key factors determining tolerance to NIV is optimal synchrony between the patient's spontaneous breathing activity and the ventilator's set parameters, known as ''patient-ventilator interaction''.
Indeed, synchronization of the ventilator breath with the patient's inspiratory effort, optimizes comfort, minimizes work of breathing and reduces the need for sedation. During NIV, several factors can significantly interfere with the function of the ventilator, leading to an increased risk of asynchrony. Indeed, the presence of unintentional leaks at the patient-mask interface, the sensitivity of inspiratory and expiratory triggers, the ability to compensate for intentional and unintentional leaks and the presence/absence of expiratory valves are all factors that likely play a role in determining patient-ventilator synchronization.
The investigators therefore designed the present crossover trial in order to compare the degree of respiratory asynchronies during NIV using different ventilators (Turbine-driven ventilator vs. compressed air-driven ICU ventilators) and different setups (single circuit vs. double circuit) in children with acute respiratory failure.
Indeed, synchronization of the ventilator breath with the patient's inspiratory effort, optimizes comfort, minimizes work of breathing and reduces the need for sedation. During NIV, several factors can significantly interfere with the function of the ventilator, leading to an increased risk of asynchrony. Indeed, the presence of unintentional leaks at the patient-mask interface, the sensitivity of inspiratory and expiratory triggers, the ability to compensate for intentional and unintentional leaks and the presence/absence of expiratory valves are all factors that likely play a role in determining patient-ventilator synchronization.
The investigators therefore designed the present crossover trial in order to compare the degree of respiratory asynchronies during NIV using different ventilators (Turbine-driven ventilator vs. compressed air-driven ICU ventilators) and different setups (single circuit vs. double circuit) in children with acute respiratory failure.
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Detailed Description
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After having obtained the signed informed consent from the parents of the patient, a 6 Fr pediatric esophageal balloon-catheter will be placed through a nostril in the distal third of the esophagus.
This minimally invasive procedure, will allow to monitor and record esophageal pressure swings, which are strongly correlated to pleural pressure variations and therefore allow to detect accurately patients' inspiratory efforts. Furthermore, surface electrodes will be placed in order to record the electrical activity of the diaphragm non-invasively.
In every patient, three breathing trials (30 minutes each) will be performed in randomized order:
1. NIV performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with a pediatric/neonatal ICU ventilator (Babylog VN500, Draeger).
2. NIV performed with a single limb circuit and intentional leak (vented mask) delivered with a turbine-driven ventilator (Astral 150 \[ResMed\] ).
3. NIV performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with the same turbine-driven ventilator of point 2 (Astral 150 \[ResMed\]).
The NIV setting decided clinically will not be modified for the study and will be held constant throughout the different study phases. Similarly, if sedative drugs are being delivered to the patient, the attending physician will decide their dose and it will be kept constant throughout the study phases. The Comfort scale will be assessed for each study phase, in order to evaluate and describe the comfort/distress of the patients during the different ventilatory strategies. Esophageal pressure tracings, inspiratory/expiratory air flows, airway pressure measured at the patient-ventilator interface and electrical activity of the diaphragm (measured with surface electrodes) will be continuously recorded with a dedicated software throughout the study in order to compute, offline, the asynchrony index (see below).
Asynchronies will be defined according to previous studies on the subject:
1. Auto-triggering (AT): a cycle delivered by the ventilator in the absence of a typical esophageal swing;
2. Ineffective Effort (IE): a deflection on the esophageal pressure monitoring not followed by an assisted cycle;
3. Late cycling (LC): a cycle with a ventilator inspiratory time greater than twice the esophageal time;
4. Premature cycling (PC): a cycle with a ventilator inspiratory time shorter than the neural inspiratory time;
5. Double triggering (DT): two ventilator-delivered cycles separated by a very short inspiratory time, during the same inspiratory Eadi signal.
The entity of asynchronies can be numerical summarized in the Asynchrony Index (AI), which is calculated as the total number of asynchrony events divided by the total number of non-triggered and triggered ventilatory cycles (expressed as percentage).
Asynchrony Index (%) = \[(AT + IE + LC + PC + DT) / (RRpes + AT)\]×100 Where AT refers to Auto-triggering, IE to ineffective triggering, LC to late cycling, PC to premature cycling, DT to double triggering and RRpes to the respiratory rate as measured using the esophageal pressure tracing.
Furthermore, the number of each type of asynchrony will be assessed (number of events per minute), in order to identify the most relevant types of asynchronies.
Randomization The randomization of the three NIV-phases will be performed with an online randomization software called "Research Randomizer" (https://www.randomizer.org). No risk of bias is foreseen, as all patients will undergo the three interventions (cross-over study).
Blinding. The respiratory traces registered during the different study phases and analyzed offline in order compute the "Asynchrony Index" will be evaluated by an investigator blinded to the type of intervention.
PRIMARY ENDPOINT Primary endpoint of the present study is the difference in Asynchrony Index (expressed as %) obtained during NIV performed with an ICU ventilator using a double limb circuit and the value obtained during NIV performed with single limb circuit with intentional leak with a turbine-driven ventilator.
Secondary endpoint Secondary endpoint of the present study is the difference in Asynchrony Index (expressed as %) obtained during NIV performed with an ICU ventilator using a double limb circuit and the value obtained with the same type of circuit, but with a turbine-driven ventilator.
STATISTICAL ANALYSIS Sample size calculation. The sample size for the primary endpoint of the study has been calculated using the software G\*Power 3.1.9.2 using a paired t-test and using as outcome parameter the difference in Asynchrony Index (AI) during NIV performed with ICU ventilators and with turbine-driven ventilators applied with single limb circuit and intentional leaks. Based on available data the investigators estimated in our population an AI of 59±13% and considered a 20% reduction of its value as clinically relevant (AI=47±13%). Considering a two-tailed alfa error of 0.05 and a desired power of 0.8, with an effect size of 0.923 the investigators calculated a sample size of 12 patients.
DATA ANALYSIS All data will be tested for homogeneity of variance and normality of distribution using the Shapiro- Wilk test. Normally distributed data will be expressed as mean ± standard deviation, while nonnormally distributed data as median and interquartile range. The presence of outliers will be carefully assessed during evaluation of distribution of data; however, no action is foreseen to exclude outliers.
Variables (Asynchrony Index, respiratory rate, tidal volume, minute ventilation, esophageal pressure variation, etc.) recorded during the different NIV modalities will be compared via paired t-test or Signed Rank Sum test, as appropriate. Mean difference and its 95% CI will be calculated for normally distributed data. For non-normally distributed variables, median difference and its 95% CI will be estimated by Hodges-Lehmann's median analysis. All tests will be two tailed and statistical significance is defined as p\<0.050. Analysis will be performed with SigmaPlot v.12.0 (Systat Software Inc., San Jose, CA) and SAS 9.2 (SAS Institute Inc., Cary, NC, USA).
Of note, the above-noted statistical procedures are appropriate but will not exclude other procedures that may also be used in addition to or in lieu of the stated procedures in order to best analyze the data. No control subjects will be needed, as each patient will serve as its own control for the subsequent measurements (cross-over study).
This minimally invasive procedure, will allow to monitor and record esophageal pressure swings, which are strongly correlated to pleural pressure variations and therefore allow to detect accurately patients' inspiratory efforts. Furthermore, surface electrodes will be placed in order to record the electrical activity of the diaphragm non-invasively.
In every patient, three breathing trials (30 minutes each) will be performed in randomized order:
1. NIV performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with a pediatric/neonatal ICU ventilator (Babylog VN500, Draeger).
2. NIV performed with a single limb circuit and intentional leak (vented mask) delivered with a turbine-driven ventilator (Astral 150 \[ResMed\] ).
3. NIV performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with the same turbine-driven ventilator of point 2 (Astral 150 \[ResMed\]).
The NIV setting decided clinically will not be modified for the study and will be held constant throughout the different study phases. Similarly, if sedative drugs are being delivered to the patient, the attending physician will decide their dose and it will be kept constant throughout the study phases. The Comfort scale will be assessed for each study phase, in order to evaluate and describe the comfort/distress of the patients during the different ventilatory strategies. Esophageal pressure tracings, inspiratory/expiratory air flows, airway pressure measured at the patient-ventilator interface and electrical activity of the diaphragm (measured with surface electrodes) will be continuously recorded with a dedicated software throughout the study in order to compute, offline, the asynchrony index (see below).
Asynchronies will be defined according to previous studies on the subject:
1. Auto-triggering (AT): a cycle delivered by the ventilator in the absence of a typical esophageal swing;
2. Ineffective Effort (IE): a deflection on the esophageal pressure monitoring not followed by an assisted cycle;
3. Late cycling (LC): a cycle with a ventilator inspiratory time greater than twice the esophageal time;
4. Premature cycling (PC): a cycle with a ventilator inspiratory time shorter than the neural inspiratory time;
5. Double triggering (DT): two ventilator-delivered cycles separated by a very short inspiratory time, during the same inspiratory Eadi signal.
The entity of asynchronies can be numerical summarized in the Asynchrony Index (AI), which is calculated as the total number of asynchrony events divided by the total number of non-triggered and triggered ventilatory cycles (expressed as percentage).
Asynchrony Index (%) = \[(AT + IE + LC + PC + DT) / (RRpes + AT)\]×100 Where AT refers to Auto-triggering, IE to ineffective triggering, LC to late cycling, PC to premature cycling, DT to double triggering and RRpes to the respiratory rate as measured using the esophageal pressure tracing.
Furthermore, the number of each type of asynchrony will be assessed (number of events per minute), in order to identify the most relevant types of asynchronies.
Randomization The randomization of the three NIV-phases will be performed with an online randomization software called "Research Randomizer" (https://www.randomizer.org). No risk of bias is foreseen, as all patients will undergo the three interventions (cross-over study).
Blinding. The respiratory traces registered during the different study phases and analyzed offline in order compute the "Asynchrony Index" will be evaluated by an investigator blinded to the type of intervention.
PRIMARY ENDPOINT Primary endpoint of the present study is the difference in Asynchrony Index (expressed as %) obtained during NIV performed with an ICU ventilator using a double limb circuit and the value obtained during NIV performed with single limb circuit with intentional leak with a turbine-driven ventilator.
Secondary endpoint Secondary endpoint of the present study is the difference in Asynchrony Index (expressed as %) obtained during NIV performed with an ICU ventilator using a double limb circuit and the value obtained with the same type of circuit, but with a turbine-driven ventilator.
STATISTICAL ANALYSIS Sample size calculation. The sample size for the primary endpoint of the study has been calculated using the software G\*Power 3.1.9.2 using a paired t-test and using as outcome parameter the difference in Asynchrony Index (AI) during NIV performed with ICU ventilators and with turbine-driven ventilators applied with single limb circuit and intentional leaks. Based on available data the investigators estimated in our population an AI of 59±13% and considered a 20% reduction of its value as clinically relevant (AI=47±13%). Considering a two-tailed alfa error of 0.05 and a desired power of 0.8, with an effect size of 0.923 the investigators calculated a sample size of 12 patients.
DATA ANALYSIS All data will be tested for homogeneity of variance and normality of distribution using the Shapiro- Wilk test. Normally distributed data will be expressed as mean ± standard deviation, while nonnormally distributed data as median and interquartile range. The presence of outliers will be carefully assessed during evaluation of distribution of data; however, no action is foreseen to exclude outliers.
Variables (Asynchrony Index, respiratory rate, tidal volume, minute ventilation, esophageal pressure variation, etc.) recorded during the different NIV modalities will be compared via paired t-test or Signed Rank Sum test, as appropriate. Mean difference and its 95% CI will be calculated for normally distributed data. For non-normally distributed variables, median difference and its 95% CI will be estimated by Hodges-Lehmann's median analysis. All tests will be two tailed and statistical significance is defined as p\<0.050. Analysis will be performed with SigmaPlot v.12.0 (Systat Software Inc., San Jose, CA) and SAS 9.2 (SAS Institute Inc., Cary, NC, USA).
Of note, the above-noted statistical procedures are appropriate but will not exclude other procedures that may also be used in addition to or in lieu of the stated procedures in order to best analyze the data. No control subjects will be needed, as each patient will serve as its own control for the subsequent measurements (cross-over study).
Conditions
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Pediatric Respiratory Diseases
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Analysis of respiratory tracings will be blinded to the type of respiratory support.
Study Groups
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Single-limb circuit with turbine-driven ventilator
Non invasive ventilation delivered with a turbine-driven ventilator, single limb with intentional leaks.
Group Type
EXPERIMENTAL
Single-Limb Turbine-Driven Ventilator
Intervention Type
DEVICE
Non invasive ventilation performed with a single limb circuit and intentional leak (vented mask) delivered with a turbine-driven ventilator (Astral 150 \[ResMed\]).
Double-limb circuit with Intensive Care Unit ventilator
Non invasive ventilation delivered with an intensive care unit ventilator with a double limb circuit.
Group Type
EXPERIMENTAL
Double-Limb Intensive Care Unit ventilator
Intervention Type
DEVICE
Non invasive ventilation performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with a pediatric/neonatal intensive care unit ventilator (Babylog VN500, Draeger).
Double-limb circuit with turbine-driven ventilator
Non invasive ventilation delivered with a turbine-driven ventilator with a double limb circuit.
Group Type
EXPERIMENTAL
Double-Limb Turbine-Driven Ventilator
Intervention Type
DEVICE
Non invasive ventilation performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with a turbine-driven ventilator (Astral 150 \[ResMed\]).
Interventions
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Single-Limb Turbine-Driven Ventilator
Non invasive ventilation performed with a single limb circuit and intentional leak (vented mask) delivered with a turbine-driven ventilator (Astral 150 \[ResMed\]).
Intervention Type
DEVICE
Double-Limb Intensive Care Unit ventilator
Non invasive ventilation performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with a pediatric/neonatal intensive care unit ventilator (Babylog VN500, Draeger).
Intervention Type
DEVICE
Double-Limb Turbine-Driven Ventilator
Non invasive ventilation performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with a turbine-driven ventilator (Astral 150 \[ResMed\]).
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Patients with acute hypoxic (SpO2/FIO2 ratio \< 315) or hypercapnic (PvCO2 \> 52 mmHg and venous pH \<7.28) respiratory failure in which non-invasive respiratory support is clinically indicated
* Age: \> 28 days and \< 4 years
* Patients whose parents provided signed informed consent
* Age: \> 28 days and \< 4 years
* Patients whose parents provided signed informed consent
Exclusion Criteria
* Age \> 4 years or \< 28 days
* Patients whose parents did not provide signed informed consent
* Clinical contraindications to non-invasive ventilation
* Clinical contraindication to the placement of an esophageal balloon
* Patients whose parents did not provide signed informed consent
* Clinical contraindications to non-invasive ventilation
* Clinical contraindication to the placement of an esophageal balloon
Minimum Eligible Age
1 Month
Maximum Eligible Age
4 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Edoardo Calderini, MD
Role: STUDY_CHAIR
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Locations
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, , Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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Facility Contacts
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Thomas Langer
Role: primary
0255033232
Giovanna Chidini
Role: backup
References
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Ganu SS, Gautam A, Wilkins B, Egan J. Increase in use of non-invasive ventilation for infants with severe bronchiolitis is associated with decline in intubation rates over a decade. Intensive Care Med. 2012 Jul;38(7):1177-83. doi: 10.1007/s00134-012-2566-4. Epub 2012 Apr 18.
Reference Type
BACKGROUND
Ottonello G, Ferrari I, Pirroddi IM, Diana MC, Villa G, Nahum L, Tuo P, Moscatelli A, Silvestri G. Home mechanical ventilation in children: retrospective survey of a pediatric population. Pediatr Int. 2007 Dec;49(6):801-5. doi: 10.1111/j.1442-200X.2007.02463.x.
Reference Type
BACKGROUND
Carlucci A, Richard JC, Wysocki M, Lepage E, Brochard L; SRLF Collaborative Group on Mechanical Ventilation. Noninvasive versus conventional mechanical ventilation. An epidemiologic survey. Am J Respir Crit Care Med. 2001 Mar;163(4):874-80. doi: 10.1164/ajrccm.163.4.2006027.
Reference Type
BACKGROUND
Tobin MJ, Jubran A, Laghi F. Patient-ventilator interaction. Am J Respir Crit Care Med. 2001 Apr;163(5):1059-63. doi: 10.1164/ajrccm.163.5.2005125. No abstract available.
Reference Type
BACKGROUND
Rabec C, Rodenstein D, Leger P, Rouault S, Perrin C, Gonzalez-Bermejo J; SomnoNIV group. Ventilator modes and settings during non-invasive ventilation: effects on respiratory events and implications for their identification. Thorax. 2011 Feb;66(2):170-8. doi: 10.1136/thx.2010.142661. Epub 2010 Oct 14.
Reference Type
BACKGROUND
Meduri GU, Conoscenti CC, Menashe P, Nair S. Noninvasive face mask ventilation in patients with acute respiratory failure. Chest. 1989 Apr;95(4):865-70. doi: 10.1378/chest.95.4.865.
Reference Type
BACKGROUND
Antonelli M, Conti G, Rocco M, Bufi M, De Blasi RA, Vivino G, Gasparetto A, Meduri GU. A comparison of noninvasive positive-pressure ventilation and conventional mechanical ventilation in patients with acute respiratory failure. N Engl J Med. 1998 Aug 13;339(7):429-35. doi: 10.1056/NEJM199808133390703.
Reference Type
BACKGROUND
Brochard L. Non-invasive ventilation for acute exacerbations of COPD: a new standard of care. Thorax. 2000 Oct;55(10):817-8. doi: 10.1136/thorax.55.10.817. No abstract available.
Reference Type
BACKGROUND
Masa JF, Corral J, Caballero C, Barrot E, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Miranda E, Mokhlesi B; Spanish Sleep Network; Garcia-Ledesma E, Sanchez-Quiroga MA, Ordax E, Gonzalez-Mangado N, Troncoso MF, Martinez-Martinez MA, Cantalejo O, Ojeda E, Carrizo SJ, Gallego B, Pallero M, Ramon MA, Diaz-de-Atauri J, Munoz-Mendez J, Senent C, Sancho-Chust JN, Ribas-Solis FJ, Romero A, Benitez JM, Sanchez-Gomez J, Golpe R, Santiago-Recuerda A, Gomez S, Bengoa M. Non-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea. Thorax. 2016 Oct;71(10):899-906. doi: 10.1136/thoraxjnl-2016-208501. Epub 2016 Jul 12.
Reference Type
BACKGROUND
Weese-Mayer DE, Silvestri JM, Menzies LJ, Morrow-Kenny AS, Hunt CE, Hauptman SA. Congenital central hypoventilation syndrome: diagnosis, management, and long-term outcome in thirty-two children. J Pediatr. 1992 Mar;120(3):381-7. doi: 10.1016/s0022-3476(05)80901-1.
Reference Type
BACKGROUND
Richard JC, Carlucci A, Breton L, Langlais N, Jaber S, Maggiore S, Fougere S, Harf A, Brochard L. Bench testing of pressure support ventilation with three different generations of ventilators. Intensive Care Med. 2002 Aug;28(8):1049-57. doi: 10.1007/s00134-002-1311-9. Epub 2002 May 30.
Reference Type
BACKGROUND
Thille AW, Lyazidi A, Richard JC, Galia F, Brochard L. A bench study of intensive-care-unit ventilators: new versus old and turbine-based versus compressed gas-based ventilators. Intensive Care Med. 2009 Aug;35(8):1368-76. doi: 10.1007/s00134-009-1467-7. Epub 2009 Apr 8.
Reference Type
BACKGROUND
Rice TW, Wheeler AP, Bernard GR, Hayden DL, Schoenfeld DA, Ware LB; National Institutes of Health, National Heart, Lung, and Blood Institute ARDS Network. Comparison of the SpO2/FIO2 ratio and the PaO2/FIO2 ratio in patients with acute lung injury or ARDS. Chest. 2007 Aug;132(2):410-7. doi: 10.1378/chest.07-0617. Epub 2007 Jun 15.
Reference Type
BACKGROUND
Fagioli D, Evangelista C, Gawronski O, Tiozzo E, Broccati F, Rava L, Dall'Oglio I; Italian COMFORT-B Study Group. Pain assessment in paediatric intensive care: the Italian COMFORT behaviour scale. Nurs Child Young People. 2018 Sep 10;30(5):27-33. doi: 10.7748/ncyp.2018.e1081.
Reference Type
BACKGROUND
Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63. doi: 10.1097/01.PCC.0000149318.40279.1A.
Reference Type
BACKGROUND
Vignaux L, Vargas F, Roeseler J, Tassaux D, Thille AW, Kossowsky MP, Brochard L, Jolliet P. Patient-ventilator asynchrony during non-invasive ventilation for acute respiratory failure: a multicenter study. Intensive Care Med. 2009 May;35(5):840-6. doi: 10.1007/s00134-009-1416-5. Epub 2009 Jan 29.
Reference Type
BACKGROUND
Piquilloud L, Vignaux L, Bialais E, Roeseler J, Sottiaux T, Laterre PF, Jolliet P, Tassaux D. Neurally adjusted ventilatory assist improves patient-ventilator interaction. Intensive Care Med. 2011 Feb;37(2):263-71. doi: 10.1007/s00134-010-2052-9. Epub 2010 Sep 25.
Reference Type
BACKGROUND
Vignaux L, Grazioli S, Piquilloud L, Bochaton N, Karam O, Levy-Jamet Y, Jaecklin T, Tourneux P, Jolliet P, Rimensberger PC. Patient-ventilator asynchrony during noninvasive pressure support ventilation and neurally adjusted ventilatory assist in infants and children. Pediatr Crit Care Med. 2013 Oct;14(8):e357-64. doi: 10.1097/PCC.0b013e3182917922.
Reference Type
BACKGROUND
Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.
Reference Type
BACKGROUND
Other Identifiers
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ASYN-VENT
Identifier Type: -
Identifier Source: org_study_id
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