Optimization of Ventilator Setting for Acute Exacerbations of Chronic Obstructive Pulmonary Disease
- Conditions
- Acute Exacerbation of Chronic Obstructive Airways Disease
- Interventions
- Procedure: Standard ventilationProcedure: Optimized ventilation
- Registration Number
- NCT01291303
- Lead Sponsor
- University of Milan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
- The needing of intubation
- The lack of informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2-standard setting of ventilation Standard ventilation 35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode. 1- optimized ventilation Optimized ventilation 35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
mortality 30 days 30-day mortality after 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.
Trial Locations
- Locations (6)
Ospedale Campo di Marte, UO Pneumologia e UTSIR
🇮🇹Lucca, LU, Italy
Ospedale Valduce, Emergency Departement
🇮🇹Como, CO, Italy
Ospedale S. Gerardo, Pneumologia, Università degli Studi di Milano-Bicocca
🇮🇹Monza, Italy
Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria
🇮🇹Bologna, BO, Italy
Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital
🇮🇹Milan, Italy
Ente Ospedaliero Cantonale, Intensive Care Unit
🇨🇭Bellinzona, Canton Ticino, Switzerland