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| Name | Class |
|---|---|
| Ospedale Campo di Marte, UO Pneumologia e UTSIR, Lucca, IT | UNKNOWN |
| Valduce Hospital | OTHER |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | OTHER |
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The analysis of flow and pressure curves generated by ventilators can be useful in the individuation of patient-ventilator asynchrony, notably in COPD patients. To date, however, a real clinical benefit of this approach to optimize ventilator setting has not been proven. The aim of the present study was to compare: optimized ventilation, driven by the analysis of flow and pressure curves, and standard setting (same initial setting, same time at the bedside, same physician, while the ventilator screen was obscured with numerical data always available). The primary aim was the normalization of pH at two hours, whilst secondary aims were change in PaCO2, respiratory rate, patient's tolerance to ventilation (all parameter evaluated at baseline, 30, 120, 360 minutes and 24 hours after the beginning of ventilation). 70 patients (26 females, aged 78±9 years, PaCO2 74±15 mmHg, pH 7.28±0.05, mean±SD) have been enrolled, with no basal difference between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1- optimized ventilation | Experimental | 35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode. |
|
| 2-standard setting of ventilation | Experimental | 35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimized ventilation | Procedure | Patients, ventilated in pressure support mode, were ventilated with initial setting PEEP and pressure support of 4 and as maximum tolerated cmH2O, inspiratory and expiratory trigger of 5 L/min and 50% of peak inspiratory flow, with changes driven by the analysis of flow and pressure curves; with a FiO2 to reach a SpO2 level between 88 and 92%. |
| Measure | Description | Time Frame |
|---|---|---|
| arterial pH | The primary outcome was the normalization of arterial pH (=pH≥7.35) at 2 hours from the beginning of non invasive ventilation | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| carbon dioxide tension in arterial blood (PaCO2) | carbon dioxide tension (mmHg) in arterial blood measured 12O, 360 minutes and 24 hours after beginning of non invasive ventilation | 120, 360 minutes and 24 hours |
| respiratory rate (RR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Nava, MD | Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria Bologna, BO, Italy | Study Chair |
| Fabiano Di Marco, MD | Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria | Bologna | BO | 40138 | Italy | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22115190 | Derived | Di Marco F, Centanni S, Bellone A, Messinesi G, Pesci A, Scala R, Perren A, Nava S. Optimization of ventilator setting by flow and pressure waveforms analysis during noninvasive ventilation for acute exacerbations of COPD: a multicentric randomized controlled trial. Crit Care. 2011;15(6):R283. doi: 10.1186/cc10567. Epub 2011 Nov 24. |
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| Ente Ospedaliero Cantonale, Bellinzona |
| OTHER |
| Azienda Ospedaliera San Gerardo di Monza | OTHER |
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|
| Standard ventilation | Procedure | Patients, ventilated in pressure support mode, were ventilated with standard setting of ventilation: -same initial setting, same time at the bedside (15 minutes at the beginning of NIV, and 5 minutes at each patients' new evaluation) same physician that "optimized ventilation" mode, while the ventilator screen was obscured (numerical data were, however, always available). |
|
respiratory rate (RR) measured 120, 360 minutes and 24 hours after the beginning of non invasive ventilation
| 120, 360 minutes and 24 hours after the beginning of ventilation |
| patient's tolerance to ventilation | The patients tolerance to ventilation was evaluated on a visual analogue scale. This scale has been used and validated in previous studies and has five scores: 1) bad; 2) poor; 3) sufficient; 4) good; and 5) very good. | 30, 120, 360 minutes and 24 hours after the beginning of ventilation |
| mortality | 30-day mortality after beginning of non invasive ventilation | 30 days |
| Ospedale Valduce, Emergency Departement |
| Como |
| CO |
| 22100 |
| Italy |
| Ospedale Campo di Marte, UO Pneumologia e UTSIR | Lucca | LU | 55100 | Italy |
| Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital | Milan | Milan | 20142 | Italy |
| Ospedale S. Gerardo, Pneumologia, Università degli Studi di Milano-Bicocca | Monza | Monza | 20052 | Italy |
| Ente Ospedaliero Cantonale, Intensive Care Unit | Bellinzona | Canton Ticino | 6500 | Switzerland |