Acute Exacerbation of Chronic Obstructive Airways Disease
Conditions
Keywords
Non invasive ventilation, acute exacerbation of COPD, optimized ventilation
Brief summary
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.
Interventions
PROCEDUREOptimized ventilation
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%.
PROCEDUREStandard ventilation
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).
Sponsors
Ospedale Campo di Marte, UO Pneumologia e UTSIR, Lucca, IT
Valduce Hospital
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Ente Ospedaliero Cantonale, Bellinzona
Azienda Ospedaliera San Gerardo di Monza
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive patients aged \> 40 years affected by COPD exacerbation (defined as an acute change in a patient's baseline dyspnoea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in therapy), and respiratory acidosis (pH \< 7.35) that were treated by NIV in addition to standard medical therapy
Exclusion criteria
* The needing of intubation * The lack of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| arterial pH | 2 hours | The primary outcome was the normalization of arterial pH (=pH≥7.35) at 2 hours from the beginning of non invasive ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| carbon dioxide tension in arterial blood (PaCO2) | 120, 360 minutes and 24 hours | carbon dioxide tension (mmHg) in arterial blood measured 12O, 360 minutes and 24 hours after beginning of non invasive ventilation |
| respiratory rate (RR) | 120, 360 minutes and 24 hours after the beginning of ventilation | respiratory rate (RR) measured 120, 360 minutes and 24 hours after the beginning of non invasive ventilation |
| patient's tolerance to ventilation | 30, 120, 360 minutes and 24 hours after the beginning of 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. |
| mortality | 30 days | 30-day mortality after beginning of non invasive ventilation |
Countries
Italy, Switzerland
Outcome results
None listed