Optimization of Ventilator Setting for Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Acute Exacerbation of Chronic Obstructive Airways Disease Clinical Trial

— NIMV01AECB  

Official title:

Optimization of Ventilator Setting by Flow and Pressure Curves Analysis During Noninvasive Ventilation for Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291303
• Other study ID #: NIMV01AECB
• Status: Completed
• Phase: N/A
• First received: February 7, 2011
• Last updated: February 7, 2011
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Exacerbation of Chronic Obstructive Airways Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Optimized 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%.
• Standard ventilation
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).

Locations

Country	Name	City	State
Italy	Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria	Bologna	BO
Italy	Ospedale Valduce, Emergency Departement	Como	CO
Italy	Ospedale Campo di Marte, UO Pneumologia e UTSIR	Lucca	LU
Italy	Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital	Milan
Italy	Ospedale S. Gerardo, Pneumologia, Università degli Studi di Milano-Bicocca	Monza
Switzerland	Ente Ospedaliero Cantonale, Intensive Care Unit	Bellinzona	Canton Ticino

Sponsors (6)

Lead Sponsor	Collaborator
University of Milan	Azienda Ospedaliera San Gerardo di Monza, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi, Ente Ospedaliero Cantonale, Bellinzona, Ospedale Campo di Marte, UO Pneumologia e UTSIR, Lucca, IT, Valduce Hospital

Countries where clinical trial is conducted

Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial pH	The primary outcome was the normalization of arterial pH (=pH=7.35) at 2 hours from the beginning of non invasive ventilation	2 hours	No
Secondary	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	120, 360 minutes and 24 hours	No
Secondary	respiratory rate (RR)	respiratory rate (RR) measured 120, 360 minutes and 24 hours after the beginning of non invasive ventilation	120, 360 minutes and 24 hours after the beginning of ventilation	No
Secondary	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.	30, 120, 360 minutes and 24 hours after the beginning of ventilation	No
Secondary	mortality	30-day mortality after beginning of non invasive ventilation	30 days	No