Dataset Information

Optimization of ventilator setting by flow and pressure waveforms analysis during noninvasive ventilation for acute exacerbations of COPD: a multicentric randomized controlled trial.

ABSTRACT: The analysis of flow and pressure waveforms generated by ventilators can be useful in the optimization of patient-ventilator interactions, notably in chronic obstructive pulmonary disease (COPD) patients. To date, however, a real clinical benefit of this approach has not been proven.The aim of the present randomized, multi-centric, controlled study was to compare optimized ventilation, driven by the analysis of flow and pressure waveforms, to standard ventilation (same physician, same initial ventilator setting, same time spent at the bedside while the ventilator screen was obscured with numerical data always available). The primary aim was the rate of pH normalization at two hours, while secondary aims were changes in PaCO2, respiratory rate and the patient's tolerance to ventilation (all parameters evaluated at baseline, 30, 120, 360 minutes and 24 hours after the beginning of ventilation). Seventy patients (35 for each group) with acute exacerbation of COPD were enrolled.Optimized ventilation led to a more rapid normalization of pH at two hours (51 vs. 26% of patients), to a significant improvement of the patient's tolerance to ventilation at two hours, and to a higher decrease of PaCO2 at two and six hours. Optimized ventilation induced physicians to use higher levels of external positive end-expiratory pressure, more sensitive inspiratory triggers and a faster speed of pressurization.The analysis of the waveforms generated by ventilators has a significant positive effect on physiological and patient-centered outcomes during acute exacerbation of COPD. The acquisition of specific skills in this field should be encouraged.ClinicalTrials.gov NCT01291303.

SUBMITTER: Di Marco F

PROVIDER: S-EPMC3388700 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Optimization of ventilator setting by flow and pressure waveforms analysis during noninvasive ventilation for acute exacerbations of COPD: a multicentric randomized controlled trial.

Di Marco Fabiano F Centanni Stefano S Bellone Andrea A Messinesi Grazia G Pesci Alberto A Scala Raffaele R Perren Andreas A Nava Stefano S

Critical care (London, England) 20111124 6

<h4>Introduction</h4>The analysis of flow and pressure waveforms generated by ventilators can be useful in the optimization of patient-ventilator interactions, notably in chronic obstructive pulmonary disease (COPD) patients. To date, however, a real clinical benefit of this approach has not been proven.<h4>Methods</h4>The aim of the present randomized, multi-centric, controlled study was to compare optimized ventilation, driven by the analysis of flow and pressure waveforms, to standard ventila ...[more]

PMID: 22115190

Similar Datasets

Project description:Motivated by a desire to understand pulmonary physiology, scientists have developed physiological lung models of varying complexity. However, pathophysiology and interactions between human lungs and ventilators, e.g., ventilator-induced lung injury (VILI), present challenges for modeling efforts. This is because the real-world pressure and volume signals may be too complex for simple models to capture, and while complex models tend not to be estimable with clinical data, limiting clinical utility. To address this gap, in this manuscript we developed a new damaged-informed lung ventilator (DILV) model. This approach relies on mathematizing ventilator pressure and volume waveforms, including lung physiology, mechanical ventilation, and their interaction. The model begins with nominal waveforms and adds limited, clinically relevant, hypothesis-driven features to the waveform corresponding to pulmonary pathophysiology, patient-ventilator interaction, and ventilator settings. The DILV model parameters uniquely and reliably recapitulate these features while having enough flexibility to reproduce commonly observed variability in clinical (human) and laboratory (mouse) waveform data. We evaluate the proof-in-principle capabilities of our modeling approach by estimating 399 breaths collected for differently damaged lungs for tightly controlled measurements in mice and uncontrolled human intensive care unit data in the absence and presence of ventilator dyssynchrony. The cumulative value of mean squares error for the DILV model is, on average, ≈12 times less than the single compartment lung model for all the waveforms considered. Moreover, changes in the estimated parameters correctly correlate with known measures of lung physiology, including lung compliance as a baseline evaluation. Our long-term goal is to use the DILV model for clinical monitoring and research studies by providing high fidelity estimates of lung state and sources of VILI with an end goal of improving management of VILI and acute respiratory distress syndrome.

Project description:BackgroundThe efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO2 clearance after 2 h of treatment.MethodsWe performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25-7.35, PaCO2 ≥ 55 mmHg before ventilator support). Primary endpoint was the mean difference of PaCO2 from baseline to 2 h (non-inferiority margin 10 mmHg) in the per-protocol analysis. Main secondary endpoints were non-inferiority of HFNT to NIV in reducing PaCO2 at 6 h in the per-protocol and intention-to-treat analysis and rate of treatment changes.ResultsSeventy-nine patients were analyzed (80 patients randomized). Mean differences for PaCO2 reduction from baseline to 2 h were - 6.8 mmHg (± 8.7) in the HFNT and - 9.5 mmHg (± 8.5) in the NIV group (p = 0.404). By 6 h, 32% of patients (13 out of 40) in the HFNT group switched to NIV and one to invasive ventilation. HFNT was statistically non-inferior to NIV since the 95% confidence interval (CI) upper boundary of absolute difference in mean PaCO2 reduction did not reach the non-inferiority margin of 10 mmHg (absolute difference 2.7 mmHg; 1-sided 95% CI 6.1; p = 0.0003). Both treatments had a significant effect on PaCO2 reductions over time, and trends were similar between groups. Similar results were found in both per-protocol at 6 h and intention-to-treat analysis.ConclusionsHFNT was statistically non-inferior to NIV as initial ventilatory support in decreasing PaCO2 after 2 h of treatment in patients with mild-to-moderate AECOPD, considering a non-inferiority margin of 10 mmHg. However, 32% of patients receiving HFNT required NIV by 6 h. Further trials with superiority design should evaluate efficacy toward stronger patient-related outcomes and safety of HFNT in AECOPD.Trial registrationThe study was prospectively registered on December 12, 2017, in ClinicalTrials.gov (NCT03370666).

Dataset Information

Optimization of ventilator setting by flow and pressure waveforms analysis during noninvasive ventilation for acute exacerbations of COPD: a multicentric randomized controlled trial.

Publications

Optimization of ventilator setting by flow and pressure waveforms analysis during noninvasive ventilation for acute exacerbations of COPD: a multicentric randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets