COPDPhase 4NCT00994552
Comparison of Pressure Support and Pressure Control Ventilation in Chronic Respiratory Failure
A Phase 4 study testing Pressure support ventilation in people with COPD and Chest Wall Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is looking at whether there is a difference in outcomes using two different types of breathing support in those patients who have chronic respiratory failure (patients who under-breathe). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Chest Wall Disease, Neuromuscular Disease
- What is being tested?
- Pressure support ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Apr 2010
- Phase
- Phase 4
- 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 chest wall deformity, neuromuscular disease or obesity hypoventilation syndrome with an FEV1/FVC ratio of >70% and VC <50% predicted or patients with COPD with a FEV1/FVC ratio of <70% an FEV1 <50% predicted
- Stable
- pH >7.35
- ESS <18
- Symptomatically stable with clinical resolution of intercurrent infection: normal C reactive protein, white cell count and afebrile
- Daytime symptoms compatible with nocturnal hypoventilation i.e. poor sleep, morning headache, daytime somnolence, shortness of breath
Show all 9Show fewer
- Arterial carbon dioxide partial pressure (PaCO2) > 6.0kPa during day with evidence of nocturnal hypoventilation (TcCO2 >7.5KPa or a rise in TcCO2 of >1 KPa)
- No prior domiciliary ventilation use
- Patients with COPD must be established on optimal medical treatment prior to enrolment
Who cannot join
- Psychological, social or geographical situation that would impair compliance with the schedule
- Patients who have underlying malignancy or severe cardiac dysfunction (ejection fraction <40%)
- Complex OSA
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Karen Ignathian, 00 44 207188 7188 ext. 85731
Kate Brignall, MB BS
About this study
Official title: A Pilot Study: Comparing Physiological Parameters and Outcome Variables Using Pressure Support Ventilation Versus Pressure Controlled Ventilation in Patients With Chronic Respiratory Failure
This study is looking at whether there is a difference in outcomes using two different types of breathing support in those patients who have chronic respiratory failure (patients who under-breathe).
There is little data to demonstrate which mode of ventilation is better in terms of physiological outcomes and outcome data relating to patient symptoms.
Read more
We hypothesize that one type of breathing support: pressure support ventilation would be more comfortable for patients as it more closely matches a patient's own respiratory pattern and and so leads to improved adherence and consequent improvement in quality of life.
Patients with respiratory failure will be randomly assigned to receive either pressure support ventilation or pressure control ventilation for the first 6 weeks and then cross-over to receive the mode not previously used for a further 6 weeks. They will have baseline data recorded and then be followed up after each 6 week block.
- Being tested
- Pressure support ventilation, Pressure control ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure support ventilationOther
Pressure support ventilation
Pressure control ventilationOther
Pressure control ventilation
| Study group | Role | What they receive |
|---|---|---|
| Pressure support ventilation | Active comparator | Pressure support ventilation Receives: Other: Pressure support ventilation |
| Pressure control ventilation | Active comparator | Pressure control ventilation Receives: Other: Pressure control ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to ventilation
Measured: 6 and 12 weeks
Secondary outcomes (9)
Arterial blood gases
Measured: 6 and 12 weeks
Health related quality of life as measured by CRQ and SRI
Measured: 6 and 12 weeks
Breathlessness (MRC dyspnoea score)
Measured: 6 and 12 weeks
Assessment of daytime vigilance and fatigue by the Epworth sleepiness score,Oxford sleep resistance test and the fatigue severity score.
Measured: 6 and 12 weeks
Sleep comfort as assessed by a visual analogue scale
Measured: 6 and 12 weeks
Spirometry: forced expiratory volume in 1s and forced vital capacity
Measured: 6 and 12 weeks
Respiratory muscle strength: maximum inspiratory pressure, maximum expiratory pressure and sniff nasal pressure
Measured: 6 and 12 weeks
Sleep fragmentation as assessed by actigraphy
Measured: 2 week perids from 4 and 10 weeks
Patient ventilator synchrony as measured by number of ineffective efforts
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2010 (estimated)
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 COPDStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- A Davidson, MA, MD, Study chair, Guys's and St Thomas' NHS foundation trustN Hart, MB BS, PhD, Principal investigator, Guy's and St Thomas' Foundation TrustK Brignall, MB ChB, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994552
- Sponsor's protocol ID
- 09/H0802/3
- Status last verified
- Oct 2009
- First submitted
- 13 Oct 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Murphy PB, Brignall K, Moxham J, Polkey MI, Davidson AC, Hart N. High pressure versus high intensity noninvasive ventilation in stable hypercapnic chronic obstructive pulmonary disease: a randomized crossover trial. Int J Chron Obstruct Pulmon Dis. 2012;7:811-8. doi: 10.2147/COPD.S36151. Epub 2012 Dec 11.
PubMed 23271905
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Comparing Physiological Parameters and Outcome Variables Using Pressure Support Ventilation Versus Pressure Controlled Ventilation in Patients With Chronic Respiratory Failure
- ClinicalTrials.gov ID
- NCT00994552
- Acronym / sponsor ID
- 09/H0802/3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (estimated)
- First posted
- 14 Oct 2009 (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.
This study is looking at whether there is a difference in outcomes using two different types of breathing support in those patients who have chronic respiratory failure (patients who under-breathe).
There is little data to demonstrate which mode of ventilation is better in terms of physiological outcomes and outcome data relating to patient symptoms.
We hypothesize that one type of breathing support: pressure support ventilation would be more comfortable for patients as it more closely matches a patient's own respiratory pattern and and so leads to improved adherence and consequent improvement in quality of life.
Patients with respiratory failure will be randomly assigned to receive either pressure support ventilation or pressure control ventilation for the first 6 weeks and then cross-over to receive the mode not previously used for a further 6 weeks. They will have baseline data recorded and then be followed up after each 6 week block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure support ventilation | Active comparator | Other: Pressure support ventilationPressure support ventilation |
| Pressure control ventilation | Active comparator | Other: Pressure control ventilationPressure control ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with chest wall deformity, neuromuscular disease or obesity hypoventilation syndrome with an FEV1/FVC ratio of >70% and VC <50% predicted or patients with COPD with a FEV1/FVC ratio of <70% an FEV1 <50% predicted
- Stable
- Daytime symptoms compatible with nocturnal hypoventilation i.e. poor sleep, morning headache, daytime somnolence, shortness of breath
- Arterial carbon dioxide partial pressure (PaCO2) > 6.0kPa during day with evidence of nocturnal hypoventilation (TcCO2 >7.5KPa or a rise in TcCO2 of >1 KPa)
- No prior domiciliary ventilation use
Key exclusion criteria (3 listed)
- Psychological, social or geographical situation that would impair compliance with the schedule
- Patients who have underlying malignancy or severe cardiac dysfunction (ejection fraction <40%)
- Complex OSA
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 |
|---|---|---|
| Pressure support ventilationPressure support ventilation | Other | Pressure support ventilation |
| Pressure control ventilationPressure control ventilation | Other | Pressure control ventilation |
Primary outcome
Adherence to ventilation
Time frame: 6 and 12 weeks
9 secondary outcomes
Arterial blood gases
Time frame: 6 and 12 weeks
Health related quality of life as measured by CRQ and SRI
Time frame: 6 and 12 weeks
Breathlessness (MRC dyspnoea score)
Time frame: 6 and 12 weeks
Assessment of daytime vigilance and fatigue by the Epworth sleepiness score,Oxford sleep resistance test and the fatigue severity score.
Time frame: 6 and 12 weeks
Sleep comfort as assessed by a visual analogue scale
Time frame: 6 and 12 weeks
Spirometry: forced expiratory volume in 1s and forced vital capacity
Time frame: 6 and 12 weeks
Respiratory muscle strength: maximum inspiratory pressure, maximum expiratory pressure and sniff nasal pressure
Time frame: 6 and 12 weeks
Sleep fragmentation as assessed by actigraphy
Time frame: 2 week perids from 4 and 10 weeks
Patient ventilator synchrony as measured by number of ineffective efforts
Time frame: 6 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
- Derived from this study: PubMed 23271905Murphy PB, Brignall K, Moxham J, Polkey MI, Davidson AC, Hart N. High pressure versus high intensity noninvasive ventilation in stable hypercapnic chronic obstructive pulmonary disease: a randomized crossover trial. Int J Chron Obstruct Pulmon Dis. 2012;7:811-8. doi: 10.2147/COPD.S36151. Epub 2012 Dec 11.
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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.
A Davidson, MA, MD study chair
Guys's and St Thomas' NHS foundation trust
N Hart, MB BS, PhD principal investigator
Guy's and St Thomas' Foundation Trust
K Brignall, MB ChB principal investigator
Guy's and St Thomas' 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 Phase 4 study testing Pressure support ventilation in people with COPD and Chest Wall Disease, run by Guy's and St Thomas' NHS Foundation Trust 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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Oct 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine Brignall, MB ChB (0044 20 7188 7188 ext. 88070, kate.brignall@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to ventilation (time frame: 6 and 12 weeks). 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 NCT00994552, 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 14 Oct 2009.