Optimization of Ventilator Setting by Flow and Pressure Curves Analysis During Noninvasive Ventilation for Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Milan
- Enrollment
- 70
- Locations
- 6
- Primary Endpoint
- arterial pH
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1- optimized ventilation
35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.
Intervention: Optimized ventilation (Procedure)
2-standard setting of ventilation
35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.
Intervention: Standard ventilation (Procedure)
Outcomes
Primary Outcomes
arterial pH
Time Frame: 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 Outcomes
- respiratory rate (RR)(120, 360 minutes and 24 hours after the beginning of ventilation)
- carbon dioxide tension in arterial blood (PaCO2)(120, 360 minutes and 24 hours)
- mortality(30 days)
- patient's tolerance to ventilation(30, 120, 360 minutes and 24 hours after the beginning of ventilation)