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

NCT01291303 | Completed

• 1 other identifier: NIMV01AECB
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 6

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.

Conditions

Acute Exacerbation of Chronic Obstructive Airways Disease

Keywords

Non invasive ventilation; acute exacerbation of COPD; optimized ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• carbon dioxide tension in arterial blood (PaCO2)

  120, 360 minutes and 24 hours

• respiratory rate (RR)

  120, 360 minutes and 24 hours after the beginning of ventilation

• patient's tolerance to ventilation

  30, 120, 360 minutes and 24 hours after the beginning of ventilation

• mortality

  30 days

Study Arms (2)

1- optimized ventilation

EXPERIMENTAL

35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.

Procedure: Optimized ventilation

2-standard setting of ventilation

EXPERIMENTAL

35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.

Procedure: Standard ventilation

Interventions

Optimized ventilation PROCEDURE

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%.

1- optimized ventilation

Standard ventilation PROCEDURE

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).

2-standard setting of ventilation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The needing of intubation
• The lack of informed consent

Sponsors & Collaborators

• University of Milan: lead
• Ospedale Campo di Marte, UO Pneumologia e UTSIR, Lucca, IT: collaborator
• Valduce Hospital: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• Ente Ospedaliero Cantonale, Bellinzona: collaborator
• Azienda Ospedaliera San Gerardo di Monza: collaborator

Study Sites (6)

Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria

Bologna, BO, 40138, Italy

Location

Ospedale Valduce, Emergency Departement

Como, CO, 22100, Italy

Location

Ospedale Campo di Marte, UO Pneumologia e UTSIR

Lucca, LU, 55100, Italy

Location

Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital

Milan, Milan, 20142, Italy

Location

Ospedale S. Gerardo, Pneumologia, Università degli Studi di Milano-Bicocca

Monza, Monza, 20052, Italy

Location

Ente Ospedaliero Cantonale, Intensive Care Unit

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 22115190 DERIVED

Study Officials

• Stefano Nava, MD

  Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria Bologna, BO, Italy

  STUDY CHAIR

• Fabiano Di Marco, MD

  Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 8, 2011
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 8, 2011

Record last verified: 2010-10

Locations

IT (5); CH (1)