Optimization of Ventilator Setting for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (NIMV01AECB)
Primary Purpose
Acute Exacerbation of Chronic Obstructive Airways Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Optimized ventilation
Standard ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Exacerbation of Chronic Obstructive Airways Disease focused on measuring Non invasive ventilation, acute exacerbation of COPD, optimized ventilation
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
Sites / Locations
- Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria
- Ospedale Valduce, Emergency Departement
- Ospedale Campo di Marte, UO Pneumologia e UTSIR
- Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital
- Ospedale S. Gerardo, Pneumologia, Università degli Studi di Milano-Bicocca
- Ente Ospedaliero Cantonale, Intensive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1- optimized ventilation
2-standard setting of ventilation
Arm Description
35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.
35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.
Outcomes
Primary Outcome Measures
arterial pH
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)
carbon dioxide tension (mmHg) in arterial blood measured 12O, 360 minutes and 24 hours after beginning of non invasive ventilation
respiratory rate (RR)
respiratory rate (RR) measured 120, 360 minutes and 24 hours after the beginning of non invasive 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.
mortality
30-day mortality after beginning of non invasive ventilation
Full Information
NCT ID
NCT01291303
First Posted
February 7, 2011
Last Updated
February 7, 2011
Sponsor
University of Milan
Collaborators
Ospedale Campo di Marte, UO Pneumologia e UTSIR, Lucca, IT, Valduce Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Ente Ospedaliero Cantonale, Bellinzona, Azienda Ospedaliera San Gerardo di Monza
1. Study Identification
Unique Protocol Identification Number
NCT01291303
Brief Title
Optimization of Ventilator Setting for Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Acronym
NIMV01AECB
Official Title
Optimization of Ventilator Setting by Flow and Pressure Curves Analysis During Noninvasive Ventilation for Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Milan
Collaborators
Ospedale Campo di Marte, UO Pneumologia e UTSIR, Lucca, IT, Valduce Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Ente Ospedaliero Cantonale, Bellinzona, Azienda Ospedaliera San Gerardo di Monza
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of Chronic Obstructive Airways Disease
Keywords
Non invasive ventilation, acute exacerbation of COPD, optimized ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1- optimized ventilation
Arm Type
Experimental
Arm Description
35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.
Arm Title
2-standard setting of ventilation
Arm Type
Experimental
Arm Description
35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.
Intervention Type
Procedure
Intervention Name(s)
Optimized ventilation
Intervention Description
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
Intervention Name(s)
Standard ventilation
Intervention Description
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).
Primary Outcome Measure Information:
Title
arterial pH
Description
The primary outcome was the normalization of arterial pH (=pH≥7.35) at 2 hours from the beginning of non invasive ventilation
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
carbon dioxide tension in arterial blood (PaCO2)
Description
carbon dioxide tension (mmHg) in arterial blood measured 12O, 360 minutes and 24 hours after beginning of non invasive ventilation
Time Frame
120, 360 minutes and 24 hours
Title
respiratory rate (RR)
Description
respiratory rate (RR) measured 120, 360 minutes and 24 hours after the beginning of non invasive ventilation
Time Frame
120, 360 minutes and 24 hours after the beginning of ventilation
Title
patient's tolerance to ventilation
Description
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.
Time Frame
30, 120, 360 minutes and 24 hours after the beginning of ventilation
Title
mortality
Description
30-day mortality after beginning of non invasive ventilation
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Nava, MD
Organizational Affiliation
Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria Bologna, BO, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fabiano Di Marco, MD
Organizational Affiliation
Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Valduce, Emergency Departement
City
Como
State/Province
CO
ZIP/Postal Code
22100
Country
Italy
Facility Name
Ospedale Campo di Marte, UO Pneumologia e UTSIR
City
Lucca
State/Province
LU
ZIP/Postal Code
55100
Country
Italy
Facility Name
Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital
City
Milan
ZIP/Postal Code
20142
Country
Italy
Facility Name
Ospedale S. Gerardo, Pneumologia, Università degli Studi di Milano-Bicocca
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Ente Ospedaliero Cantonale, Intensive Care Unit
City
Bellinzona
State/Province
Canton Ticino
ZIP/Postal Code
6500
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22115190
Citation
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.
Results Reference
derived
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Optimization of Ventilator Setting for Acute Exacerbations of Chronic Obstructive Pulmonary Disease
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