Respiratory FailureNCT01644162
Ventilator Monitoring in Early Exacerbation Detection
A study testing iVAPS ventilation in people with Respiratory Failure and Neuromuscular Disease, run by ResMed at 1 site in United Kingdom.
Trial summary
The aim of this study is to determine whether respiratory disease exacerbations (a sudden worsening of symptoms) can be predicted by variables that are monitored by non-invasive ventilators (small machines that assist breathing) in patients requiring long term home ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Neuromuscular Disease, Chest Wall Disorder
- What is being tested?
- iVAPS ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Jan 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of obstructive (COPD, cystic fibrosis, bronchiectasis or chronic asthma) or restrictive (NMD, chest wall disorder) lung disease confirmed by a hospital consultant
- aged > 18 years
- established home ventilator user with ventilator prescribed for either chronic ventilatory failure or nocturnal hypoventilation
- able to use bilevel positive pressure ventilation with Inspiratory positive airway pressure (IPAP) requirement <30cm H2O (Stellar ventilator - IPAP max 30)
Who cannot join
- patients < 18 years
- cognitive impairment sufficient to interfere with comprehension of the study or use of ventilator
- poor adherence with non-invasive ventilation (<3hours/night for >10days/month)
- Inspiratory positive airway pressure (IPAP) requirement >30cmH2O
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Ventilator Monitoring for Early Detection of Exacerbations of Chronic Lung Disease
The aim of this study is to determine whether respiratory disease exacerbations (a sudden worsening of symptoms) can be predicted by variables that are monitored by non-invasive ventilators (small machines that assist breathing) in patients requiring long term home ventilation.
The investigators hypothesise that acute exacerbations of patients with respiratory disease and ventilatory failure will be predicted by changes in the respiratory variables monitored and stored by ventilators during chronic home ventilator use.
Read the detailed description
This pilot study is a proof of concept study investigating whether respiratory variables measured during chronic non-invasive ventilation (NIV) therapy may be used to predict a disease exacerbation.
Modern ventilators used in the home for chronic respiratory failure have the ability to monitor and store respiratory variables that may worsen during exacerbations, and may potentially detect exacerbations before symptoms become apparent. Normal pressure support ventilators monitor respiratory rate which might be expected to increase with worsening disease. In patients with obstructive airways disease an increase in expiratory time may potentially be observed with worsening airways obstruction. Adaptive servo ventilators, which modulate pressure support to maintain constant minute ventilation, may increase the amount of pressure support delivered if respiratory mechanics deteriorate as a result of an exacerbation.
Consenting experienced NIV users will be switched to an adaptive-servo ventilator with the capacity to monitor and store therapy data. The device being used is the Stellar 150 ventilator (Resmed, Ltd., Bella Vista, Australia) with hardware and software ability to measure variables such as respiratory rate, airflow, pressure support and leak.
Patients will use the ventilator for a total of 4 months during which they will complete daily symptom diaries, including medication use and peak flow measurements.
Changes in ventilator variables will be analysed and day to day variation identified. Changes will be compared with daily peak expiratory flow measures (an indication of how well the airways are functioning), patient symptoms, and healthcare utilization. Hospital admissions for exacerbations, GP consults, and healthcare team contacts will also be measured.
- Conditions
- Respiratory Failure, Neuromuscular Disease, Chest Wall Disorder, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome
- Being tested
- iVAPS ventilation
- Keywords
- Non-Invasive Positive-Pressure Ventilation, Disease Exacerbation, Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency, Neuromuscular Diseases, Pulmonary Disease, Chronic Obstructive, Obesity Hypoventilation Syndrome, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iVAPS ventilationDevice
Also called non-invasive ventilation
3 months of ventilation on iVAPS mode
| Study group | Role | What they receive |
|---|---|---|
| iVAPS ventilation | Other | 3 months of ventilator use in iVAPS mode with data monitoring Receives: Device: iVAPS ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ventilator pressure support from baseline
Pressure Support delivered by the adaptive-servo ventilator at Day 0 of exacerbation compared to the pressure support during baseline stable state.
Measured: up to 3 months
Secondary outcomes (4)
Changes in ventilator-measured parameters from baseline
Changes in ventilator-measured parameters >15% from baseline [respiratory rate (RR), inspiratory time (Ti), pressure support (PS), Minute volume (MV), tidal volume (Vt), flow, leak, oxygen saturation (SaO2), pulse, I:E ratio, apnoea-hypopnea index (AHI), compliance]
Measured: Up to 3 months
Exacerbation as determined by a change in patients subjective symptoms
The presence of 2 or more subjective symptoms compared to baseline for 2 consecutive days;
- breathlessness, increased sputum volume or sputum purulence, coryzal, wheeze or chest tightness, sore throat, cough, fever, sleep disruption, decreased physical activity
Measured: up to 3 months
Change in peak expiratory flow rate (PEFR)>15% from baseline
Change in peak expiratory flow rate (PEFR)>15% from baseline
Measured: Up to 3 months
Exacerbation as defined by healthcare utilisation
Exacerbation defined by the requirement of antibiotics +/- steroids, GP visit, accident and emergency visit, hospital admission
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anita Simonds, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644162
- Sponsor's protocol ID
- 11/LO/1777
- Status last verified
- Mar 2012
- First submitted
- 16 Jul 2012
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ventilator Monitoring for Early Detection of Exacerbations of Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT01644162
- Acronym / sponsor ID
- 11/LO/1777
- Conditions
- Respiratory Failure, Neuromuscular Disease, Chest Wall Disorder, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome
- Keywords
- Non-Invasive Positive-Pressure Ventilation, Disease Exacerbation, Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Jul 2012 (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 aim of this study is to determine whether respiratory disease exacerbations (a sudden worsening of symptoms) can be predicted by variables that are monitored by non-invasive ventilators (small machines that assist breathing) in patients requiring long term home ventilation.
The investigators hypothesise that acute exacerbations of patients with respiratory disease and ventilatory failure will be predicted by changes in the respiratory variables monitored and stored by ventilators during chronic home ventilator use.
Detailed description
This pilot study is a proof of concept study investigating whether respiratory variables measured during chronic non-invasive ventilation (NIV) therapy may be used to predict a disease exacerbation.
Modern ventilators used in the home for chronic respiratory failure have the ability to monitor and store respiratory variables that may worsen during exacerbations, and may potentially detect exacerbations before symptoms become apparent. Normal pressure support ventilators monitor respiratory rate which might be expected to increase with worsening disease. In patients with obstructive airways disease an increase in expiratory time may potentially be observed with worsening airways obstruction. Adaptive servo ventilators, which modulate pressure support to maintain constant minute ventilation, may increase the amount of pressure support delivered if respiratory mechanics deteriorate as a result of an exacerbation.
Consenting experienced NIV users will be switched to an adaptive-servo ventilator with the capacity to monitor and store therapy data. The device being used is the Stellar 150 ventilator (Resmed, Ltd., Bella Vista, Australia) with hardware and software ability to measure variables such as respiratory rate, airflow, pressure support and leak.
Patients will use the ventilator for a total of 4 months during which they will complete daily symptom diaries, including medication use and peak flow measurements.
Changes in ventilator variables will be analysed and day to day variation identified. Changes will be compared with daily peak expiratory flow measures (an indication of how well the airways are functioning), patient symptoms, and healthcare utilization. Hospital admissions for exacerbations, GP consults, and healthcare team contacts will also be measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iVAPS ventilation | Other | Device: iVAPS ventilation3 months of ventilator use in iVAPS mode with data monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a diagnosis of obstructive (COPD, cystic fibrosis, bronchiectasis or chronic asthma) or restrictive (NMD, chest wall disorder) lung disease confirmed by a hospital consultant
- aged > 18 years
- established home ventilator user with ventilator prescribed for either chronic ventilatory failure or nocturnal hypoventilation
- able to use bilevel positive pressure ventilation with Inspiratory positive airway pressure (IPAP) requirement <30cm H2O (Stellar ventilator - IPAP max 30)
Key exclusion criteria (4 listed)
- patients < 18 years
- cognitive impairment sufficient to interfere with comprehension of the study or use of ventilator
- poor adherence with non-invasive ventilation (<3hours/night for >10days/month)
- Inspiratory positive airway pressure (IPAP) requirement >30cmH2O
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 |
|---|---|---|
| iVAPS ventilationAlso: non-invasive ventilation3 months of ventilation on iVAPS mode | Device | iVAPS ventilation |
Primary outcome
Change in ventilator pressure support from baseline
Time frame: up to 3 months
Pressure Support delivered by the adaptive-servo ventilator at Day 0 of exacerbation compared to the pressure support during baseline stable state.
4 secondary outcomes
Changes in ventilator-measured parameters from baseline
Time frame: Up to 3 months
Exacerbation as determined by a change in patients subjective symptoms
Time frame: up to 3 months
Change in peak expiratory flow rate (PEFR)>15% from baseline
Time frame: Up to 3 months
Exacerbation as defined by healthcare utilisation
Time frame: up to 3 months
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 17 Oct 2014.
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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.
Anita Simonds principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iVAPS ventilation in people with Respiratory Failure and Neuromuscular Disease, run by ResMed at 1 site in United Kingdom.
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 4 inclusion and 4 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 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Change in ventilator pressure support from baseline (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2014.