Respiratory FailureNCT01174316
Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Acute Exacerbation of Respiratory Failure
A study testing AutoVPAP™ and VPAPIIIST-A™ in people with Respiratory Failure and Neuromuscular Disease, run by ResMed at 1 site in United Kingdom.
Trial summary
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure. 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?
- AutoVPAP™ and VPAPIIIST-A™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to 10 May 2011
- 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 admitted or transferred to Royal Brompton Hospital with acute exacerbation of chronic respiratory failure, or inpatients who suffer a deterioration in respiratory status, defined as 7.25 < pH < 7.35, PaCO2 > 6.0kPa, and respiratory rate > 20bpm
Who cannot join
- < 18 years old
- pH < 7.25
- need for immediate intubation
- uncontrolled cardiac failure
- hypotensive (systolic blood pressure < 90mmHg)
- acute myocardial infarction
Show all 10Show fewer
- acute dysrhythmia
- other system failure (e.g. acute renal failure, liver failure)
- moderate or severe bulbar weakness
- inability to understand rationale and/or consent form for study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Acute Exacerbation of Chronic Respiratory Failure
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure.
The investigators hypothesise that autotitrating NIV will ventilate patients with acute exacerbations of chronic respiratory failure as effectively as standard NIV.
Read the detailed description
The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients admitted to hospital with a sudden worsening of their existing breathing insufficiency, including an increase of carbon dioxide in the blood (hypercapnia) and acidity of the blood. Noninvasive ventilation (NIV) is standard therapy for patients with acute hypercapnic exacerbations (sudden worsening of existing breathing insufficiency) of both chronic obstructive pulmonary disease (COPD) and nonCOPD patients.
The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.
Patients over the age of 18 admitted to Royal Brompton Hospital respiratory ward will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. After 24 hours on the first NIV the patient will be swapped to the alternative NIV for a further 24 hours of treatment.
- Conditions
- Respiratory Failure, Neuromuscular Disease, Chest Wall Disorder, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome
- Being tested
- AutoVPAP™, VPAPIIIST-A™
- Keywords
- Acute exacerbation, Respiratory insufficiency, Respiratory failure, Hypercapnia, Hypoventilation, Sleep, Hypoxia, Titration, Non Invasive Ventilation
- Medical subject headings
- Respiratory Insufficiency, Neuromuscular Diseases, Pulmonary Disease, Chronic Obstructive, Obesity Hypoventilation Syndrome, Hypercapnia, Hypoventilation, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoVPAP™Device
Also called autotitrating variable positive airway pressure, autotitrating NIV, automatically titrating NIV
Automatically titrated non-invasive ventilator, with target gross alveolar ventilation, end expiratory positive pressure, and back up respiratory rate determined by the clinician based on height and weight. The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
VPAPIIIST-A™Device
Also called standard NIV, standard non-invasive ventilator, variable positive airway pressure, VPAP
Standard non-invasive ventilator, with inspiratory and expiratory positive pressure determined by the healthcare professional. The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
| Study group | Role | What they receive |
|---|---|---|
| autotitrating NIV | Experimental | approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital Receives: Device: AutoVPAP™ |
| Standard non-invasive ventilation | Active comparator | approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital. Receives: Device: VPAPIIIST-A™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH at 1+ hour
pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value
Measured: 1 hour
Secondary outcomes (8)
pH at 4+ hours
pH of arterial blood after 4 hours of treatment with non-invasive ventialtion compared to baseline value
Measured: 4+ hours of NIV treatment
Respiratory Rate at 1+ hour
Respiratory rate after 1 hour of treatment with non-invasive ventilation compared to baseline value
Measured: 1+ hour of NIV treatment
Respiratory rate at 4+ hours
Respiratory rate after 4 hours of treatment with non-invasive ventilation compared to baseline value
Measured: 4+ hours of NIV treatment
overnight mean transcutaneous carbon dioxide
mean overnight transcutaneous carbon dioxide during sleep period
Measured: 24 hours
PaCO2 at 1+ hours
Carbon dixoide level of arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline
Measured: 1+ hours of NIV treatment
PaCO2 at 4+ hours
Carbon dioxide level in arterial blood after 4 hours of treatment with non-invasive ventilation compared to baseline value
Measured: 4+ hours of NIV treatment
PaO2 at 1+ hour
Oxygen level in arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline value
Measured: 1+ hour of NIV treatment
PaO2 at 4+ hours
Oxygen level in arterial blood after 4+ hours of treatment with non-invasive ventilation compared to baseline value
Measured: 4+ hours of NIV treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startAug 2010
- Primary completion1 Mar 2011
- Study completion10 May 2011
Why it stopped: difficulty recruiting
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Anita Simonds, MD, FRCP, Principal investigator, Royal Brompton & Harefield Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174316
- Sponsor's protocol ID
- 10/H0808/56
- Other IDs
- R&D No. 2010LF008B, CI/2010/0027
- Status last verified
- Apr 2021
- First submitted
- 2 Aug 2010
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Acute Exacerbation of Chronic Respiratory Failure
- ClinicalTrials.gov ID
- NCT01174316
- Acronym / sponsor ID
- 10/H0808/56
- Conditions
- Respiratory Failure, Neuromuscular Disease, Chest Wall Disorder, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome
- Keywords
- Acute exacerbation, Respiratory insufficiency, Respiratory failure, Hypercapnia, Hypoventilation, Sleep, Hypoxia, Titration
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulty recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- Aug 2010 (actual)
- Primary completion
- 1 Mar 2011 (actual)
- Study completion
- 10 May 2011 (actual)
- First posted
- 3 Aug 2010 (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 the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure.
The investigators hypothesise that autotitrating NIV will ventilate patients with acute exacerbations of chronic respiratory failure as effectively as standard NIV.
Detailed description
The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients admitted to hospital with a sudden worsening of their existing breathing insufficiency, including an increase of carbon dioxide in the blood (hypercapnia) and acidity of the blood. Noninvasive ventilation (NIV) is standard therapy for patients with acute hypercapnic exacerbations (sudden worsening of existing breathing insufficiency) of both chronic obstructive pulmonary disease (COPD) and nonCOPD patients.
The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.
Patients over the age of 18 admitted to Royal Brompton Hospital respiratory ward will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. After 24 hours on the first NIV the patient will be swapped to the alternative NIV for a further 24 hours of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autotitrating NIV | Experimental | Device: AutoVPAP™approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital |
| Standard non-invasive ventilation | Active comparator | Device: VPAPIIIST-A™approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients admitted or transferred to Royal Brompton Hospital with acute exacerbation of chronic respiratory failure, or inpatients who suffer a deterioration in respiratory status, defined as 7.25 < pH < 7.35, PaCO2 > 6.0kPa, and respiratory rate > 20bpm
Key exclusion criteria (10 listed)
- < 18 years old
- pH < 7.25
- need for immediate intubation
- uncontrolled cardiac failure
- hypotensive (systolic blood pressure < 90mmHg)
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 |
|---|---|---|
| AutoVPAP™Also: autotitrating variable positive airway pressure, autotitrating NIV, automatically titrating NIVAutomatically titrated non-invasive ventilator, with target gross alveolar ventilation, end expiratory positive pressure, and back up respiratory rate determined by the clinician based on height and weight. The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed. | Device | autotitrating NIV |
| VPAPIIIST-A™Also: standard NIV, standard non-invasive ventilator, variable positive airway pressure, VPAPStandard non-invasive ventilator, with inspiratory and expiratory positive pressure determined by the healthcare professional. The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed. | Device | Standard non-invasive ventilation |
Primary outcome
pH at 1+ hour
Time frame: 1 hour
pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value
8 secondary outcomes
pH at 4+ hours
Time frame: 4+ hours of NIV treatment
Respiratory Rate at 1+ hour
Time frame: 1+ hour of NIV treatment
Respiratory rate at 4+ hours
Time frame: 4+ hours of NIV treatment
overnight mean transcutaneous carbon dioxide
Time frame: 24 hours
PaCO2 at 1+ hours
Time frame: 1+ hours of NIV treatment
PaCO2 at 4+ hours
Time frame: 4+ hours of NIV treatment
PaO2 at 1+ hour
Time frame: 1+ hour of NIV treatment
PaO2 at 4+ hours
Time frame: 4+ hours of NIV treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
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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, MD, FRCP principal investigator
Royal Brompton & Harefield Hospital NHS 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 AutoVPAP™ and VPAPIIIST-A™ 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 1 inclusion and 10 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: withdrawn, as of the sponsor's last update on 19 Apr 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
pH at 1+ hour (time frame: 1 hour). 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 19 Apr 2021.