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

This study has been completed.
Sponsor:
Collaborators:
Ospedale Campo di Marte, UO Pneumologia e UTSIR, Lucca, IT
Valduce Hospital
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Ente Ospedaliero Cantonale, Bellinzona
Azienda Ospedaliera San Gerardo di Monza
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT01291303
First received: February 7, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Acute Exacerbation of Chronic Obstructive Airways Disease
Procedure: Optimized ventilation
Procedure: Standard ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Optimization of Ventilator Setting by Flow and Pressure Curves Analysis During Noninvasive Ventilation for Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • arterial pH [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The primary outcome was the normalization of arterial pH (=pH≥7.35) at 2 hours from the beginning of non invasive ventilation


Secondary Outcome Measures:
  • carbon dioxide tension in arterial blood (PaCO2) [ Time Frame: 120, 360 minutes and 24 hours ] [ Designated as safety issue: No ]
    carbon dioxide tension (mmHg) in arterial blood measured 12O, 360 minutes and 24 hours after beginning of non invasive ventilation

  • respiratory rate (RR) [ Time Frame: 120, 360 minutes and 24 hours after the beginning of ventilation ] [ Designated as safety issue: No ]
    respiratory rate (RR) measured 120, 360 minutes and 24 hours after the beginning of non invasive ventilation

  • patient's tolerance to ventilation [ Time Frame: 30, 120, 360 minutes and 24 hours after the beginning of ventilation ] [ Designated as safety issue: No ]
    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.

  • mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    30-day mortality after beginning of non invasive ventilation


Enrollment: 70
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291303

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

No publications provided by University of Milan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Fabiano Di Marco, Respiratory Unit, San Paolo Hospital, University of Milan, Milan, Italy
ClinicalTrials.gov Identifier: NCT01291303     History of Changes
Other Study ID Numbers: NIMV01AECB
Study First Received: February 7, 2011
Last Updated: February 7, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
Non invasive ventilation
acute exacerbation of COPD
optimized ventilation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014