Optimization of Ventilator Setting for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (NIMV01AECB)

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

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 Overview

• Status: Completed
• Conditions: Acute Exacerbation of Chronic Obstructive Airways Disease
• Intervention / Treatment: Procedure: Optimized ventilation; Procedure: Standard ventilation

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20142
    • Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital
  • Monza, Italy, 20052
    • Ospedale S. Gerardo, Pneumologia, Università degli Studi di Milano-Bicocca
  • BO
    • Bologna, BO, Italy, 40138
      • Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria
  • CO
    • Como, CO, Italy, 22100
      • Ospedale Valduce, Emergency Departement
  • LU
    • Lucca, LU, Italy, 55100
      • Ospedale Campo di Marte, UO Pneumologia e UTSIR
• Switzerland
  • Canton Ticino
    • Bellinzona, Canton Ticino, Switzerland, 6500
      • Ente Ospedaliero Cantonale, Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1- optimized ventilation; 35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.	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%.
EXPERIMENTAL: 2-standard setting of ventilation; 35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
mortality	30-day mortality after beginning of non invasive ventilation	30 days

Collaborators and Investigators

• Sponsor: University of Milan
• Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna; Valduce Hospital; Ente Ospedaliero Cantonale, Bellinzona; Azienda Ospedaliera San Gerardo di Monza; Ospedale Campo di Marte, UO Pneumologia e UTSIR, Lucca, IT
• Investigators: Study Chair: Stefano Nava, MD, Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria Bologna, BO, Italy; Study Director: Fabiano Di Marco, MD, Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: February 7, 2011
• First Submitted That Met QC Criteria: February 7, 2011
• First Posted (ESTIMATE): February 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 8, 2011
• Last Update Submitted That Met QC Criteria: February 7, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Non invasive ventilation; acute exacerbation of COPD; optimized ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: NIMV01AECB