An interventional study of Optimized ventilation and Standard ventilation in Acute Exacerbation of Chronic Obstructive Airways Disease, sponsored by University of Milan. Completed at 6 sites in 2 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2011-02-08.
Sponsored by University of Milan · Not applicable, Interventional, and Treatment
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.
2,591 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 70 is close to the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.
Procedure: Optimized ventilation
35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.
Procedure: Standard 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%.
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).
arterial pH
The primary outcome was the normalization of arterial pH (=pH≥7.35) at 2 hours from the beginning of non invasive ventilation
Time frame: 2 hours
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
Time frame: 120, 360 minutes and 24 hours
respiratory rate (RR)
respiratory rate (RR) measured 120, 360 minutes and 24 hours after the beginning of non invasive ventilation
Time frame: 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.
Time frame: 30, 120, 360 minutes and 24 hours after the beginning of ventilation
mortality
30-day mortality after beginning of non invasive ventilation
Time frame: 30 days
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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University of Milan