Clinical trial NCT01291303: Optimization of Ventilator Setting for Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Official title: Optimization of Ventilator Setting by Flow and Pressure Curves Analysis During Noninvasive Ventilation for Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Exacerbation of Chronic Obstructive Airways Disease
Keywords: Non invasive ventilation
acute exacerbation of COPD
optimized ventilation
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: Ospedale Campo di Marte, UO Pneumologia e UTSIR, Lucca, IT
name: Valduce Hospital
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Ente Ospedaliero Cantonale, Bellinzona
name: Azienda Ospedaliera San Gerardo di Monza
First posted: 2011-02-08
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: arterial pH
timeFrame: 2 hours
Secondary outcomes:
measure: carbon dioxide tension in arterial blood (PaCO2)
timeFrame: 120, 360 minutes and 24 hours
measure: respiratory rate (RR)
timeFrame: 120, 360 minutes and 24 hours after the beginning of ventilation
measure: patient's tolerance to ventilation
timeFrame: 30, 120, 360 minutes and 24 hours after the beginning of ventilation
measure: mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria
state: BO
city: Como
country: Italy
facility: Ospedale Valduce, Emergency Departement
state: CO
city: Lucca
country: Italy
facility: Ospedale Campo di Marte, UO Pneumologia e UTSIR
state: LU
city: Milan
country: Italy
facility: Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital
city: Monza
country: Italy
facility: Ospedale S. Gerardo, Pneumologia, Università degli Studi di Milano-Bicocca
city: Bellinzona
country: Switzerland
facility: Ente Ospedaliero Cantonale, Intensive Care Unit
state: Canton Ticino
Study officials:
affiliation: Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria Bologna, BO, Italy
name: Stefano Nava, MD
role: STUDY_CHAIR
affiliation: Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital
name: Fabiano Di Marco, MD
role: STUDY_DIRECTOR
References:
citation: Di Marco F, Centanni S, Bellone A, Messinesi G, Pesci A, Scala R, Perren A, Nava S. Optimization of ventilator setting by flow and pressure waveforms analysis during noninvasive ventilation for acute exacerbations of COPD: a multicentric randomized controlled trial. Crit Care. 2011;15(6):R283. doi: 10.1186/cc10567. Epub 2011 Nov 24.