Acute Exacerbation of Chronic Obstructive Airways DiseaseNIMV01AECBNCT01291303
Optimization of Ventilator Setting for Acute Exacerbations of Chronic Obstructive Pulmonary Disease
A study testing Optimized ventilation and Standard ventilation in people with Acute Exacerbation of Chronic Obstructive Airways Disease, run by University of Milan at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Airways Disease
- What is being tested?
- Optimized ventilation and Standard ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- The needing of intubation
- The lack of informed consent
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Italy5 sites
Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria
Bologna, BO, 40138
Ospedale Valduce, Emergency Departement
Como, CO, 22100
Ospedale Campo di Marte, UO Pneumologia e UTSIR
Lucca, LU, 55100
Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital
Milan, Milan, 20142
Ospedale S. Gerardo, Pneumologia, Università degli Studi di Milano-Bicocca
Monza, Monza, 20052
Switzerland1 site
Ente Ospedaliero Cantonale, Intensive Care Unit
Bellinzona, Canton Ticino, 6500
About this study
Official title: 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.
- Being tested
- Optimized ventilation, Standard ventilation
- Keywords
- Non invasive ventilation, acute exacerbation of COPD, optimized ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized ventilationProcedure or surgery
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%.
Standard ventilationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 1- optimized ventilation | Experimental | 35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode. Receives: Procedure: Optimized ventilation |
| 2-standard setting of ventilation | Experimental | 35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode. Receives: Procedure: Standard ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial pH
The primary outcome was the normalization of arterial pH (=pH≥7.35) at 2 hours from the beginning of non invasive ventilation
Measured: 2 hours
Secondary outcomes (4)
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
Measured: 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
Measured: 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.
Measured: 30, 120, 360 minutes and 24 hours after the beginning of ventilation
mortality
30-day mortality after beginning of non invasive ventilation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation of Chronic Obstructive Airways DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Stefano Nava, MD, Study chair, Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria Bologna, BO, ItalyFabiano Di Marco, MD, Study director, Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291303
- Sponsor's protocol ID
- NIMV01AECB
- Acronym
- NIMV01AECB
- Status last verified
- Oct 2010
- First submitted
- 7 Feb 2011
- Last updated
- 8 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22115190
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Ventilator Setting by Flow and Pressure Curves Analysis During Noninvasive Ventilation for Acute Exacerbations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01291303
- Acronym / sponsor ID
- NIMV01AECB / NIMV01AECB
- Keywords
- Non invasive ventilation, acute exacerbation of COPD, optimized ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- 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
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- optimized ventilation | Experimental | Procedure: Optimized ventilation35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode. |
| 2-standard setting of ventilation | Experimental | Procedure: Standard ventilation35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- The needing of intubation
- The lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized ventilationPatients, 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%. | Procedure or surgery | 1- optimized ventilation |
| Standard ventilationPatients, 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). | Procedure or surgery | 2-standard setting of ventilation |
Primary outcome
arterial pH
Time frame: 2 hours
The primary outcome was the normalization of arterial pH (=pH≥7.35) at 2 hours from the beginning of non invasive ventilation
4 secondary outcomes
carbon dioxide tension in arterial blood (PaCO2)
Time frame: 120, 360 minutes and 24 hours
respiratory rate (RR)
Time frame: 120, 360 minutes and 24 hours after the beginning of ventilation
patient's tolerance to ventilation
Time frame: 30, 120, 360 minutes and 24 hours after the beginning of ventilation
mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2011.
- Derived from this study: PubMed 22115190Di 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Nava, MD study chair
Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria Bologna, BO, Italy
Fabiano Di Marco, MD study director
Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized ventilation and Standard ventilation in people with Acute Exacerbation of Chronic Obstructive Airways Disease, run by University of Milan at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial pH (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2011.