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

NCT ID: NCT01291303

Last Updated: 2011-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1- optimized ventilation

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

Group Type: EXPERIMENTAL

Optimized ventilation

Intervention Type: 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%.

2-standard setting of ventilation

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

Group Type: EXPERIMENTAL

Standard ventilation

Intervention Type: 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).

Interventions

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%.

Intervention Type: 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).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Campo di Marte, UO Pneumologia e UTSIR, Lucca, IT

UNKNOWN

Sponsor Role: collaborator

Valduce Hospital

OTHER

Sponsor Role: collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: collaborator

Ente Ospedaliero Cantonale, Bellinzona

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera San Gerardo di Monza

OTHER

Sponsor Role: collaborator

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Respiratory Unit, San Paolo Hospital, University of Milan, Milan, Italy

Principal Investigators

Stefano Nava, MD

Role: STUDY_CHAIR

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

Fabiano Di Marco, MD

Role: STUDY_DIRECTOR

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

Locations

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, Milan, Italy

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

Monza, Monza, Italy

Ente Ospedaliero Cantonale, Intensive Care Unit

Bellinzona, Canton Ticino, Switzerland

Countries

Italy; Switzerland

References

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.

Reference Type: DERIVED

PMID: 22115190 (View on PubMed)

Other Identifiers

NIMV01AECB

Identifier Type: -

Identifier Source: org_study_id