Chronic Hypercapnic Respiratory FailurePhase 2NCT01371149
Patient -Ventilator Interaction in Chronic Respiratory Failure
A Phase 2 study testing Surface parasternal electromyography (EMG) set up in people with Chronic Hypercapnic Respiratory Failure and Obesity Hypoventilation Syndrome, run by Michelle Ramsay at 2 sites in United Kingdom.
Trial summary
To evaluate a novel advanced physiological monitoring system to improve nocturnal non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD), Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Hypercapnic Respiratory Failure, Obesity Hypoventilation Syndrome, Neuromuscular Disease
- What is being tested?
- Surface parasternal electromyography (EMG) set up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2011to Apr 2014
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over the age of 16 years.
- Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome.
- Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of >6.0 kPa in the morning.
- Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of >6.0 kPa during the day.
- No prior domiciliary ventilation.
Who cannot join
- Patients with other co-morbidities e.g. cancer or cardiac failure.
- Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease.
- Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation.
- Patients who have an abnormal bleeding tendency (INR or APTTr >1.4 or platelets <100).
- Patients with a psychological, social or geographical situation that would impair compliance with the project.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Guy's and St. Thomas' NHS Trust
London, SE1 7EH
Royal Brompton Hospital
London, SW3 6NP
About this study
Official title: A Clinical Trial to Optimise Patient-ventilator Interaction in Patients With Chronic Respiratory Failure
To evaluate a novel advanced physiological monitoring system to improve nocturnal non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD), Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) patients. By enhancing sleep comfort, adherence to ventilation will increase which, in turn, will improve ventilatory failure, quality of life and reduce length of admission during initiation of therapy. We aim to incorporate this technology into routine clinical practice.
- Conditions
- Chronic Hypercapnic Respiratory Failure, Obesity Hypoventilation Syndrome, Neuromuscular Disease, Chronic Obstructive Pulmonary Disease
- Being tested
- Surface parasternal electromyography (EMG) set up
- Medical subject headings
- Obesity Hypoventilation Syndrome, Neuromuscular Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface parasternal electromyography (EMG) set upOther
Ventilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony.
| Study group | Role | What they receive |
|---|---|---|
| Physician led ventilator set up | No intervention | Patients will be set up on non-invasive ventilation as per the current gold standard physician led approach |
| parasternal electromyography (EMG) set up | Experimental | Ventilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony. Receives: Other: Surface parasternal electromyography (EMG) set up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence with ventilation
Data on patient reported compliance and ventilator recorded compliance will be collected.
Measured: 3 months
Secondary outcomes (3)
health related quality of life
SRI, RAND-36, visual analogue scores, St. George's respiratory questionnaire
Measured: 3 month
length of hospital stay for initiation of home mechanical ventilation
Measured: 3 months
gas exchange
overnight oximetry, overnight capnography,arterial oxygenation, arterial carbon dioxide
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hypercapnic Respiratory FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelle Ramsay
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Michelle Ramsay, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371149
- Sponsor's protocol ID
- 10/H0716/67
- Status last verified
- Apr 2014
- First submitted
- 9 Jun 2011
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Optimise Patient-ventilator Interaction in Patients With Chronic Respiratory Failure
- ClinicalTrials.gov ID
- NCT01371149
- Acronym / sponsor ID
- 10/H0716/67
- Conditions
- Chronic Hypercapnic Respiratory Failure, Obesity Hypoventilation Syndrome, Neuromuscular Disease, Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Michelle RamsayUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Jun 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.
To evaluate a novel advanced physiological monitoring system to improve nocturnal non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD), Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) patients. By enhancing sleep comfort, adherence to ventilation will increase which, in turn, will improve ventilatory failure, quality of life and reduce length of admission during initiation of therapy. We aim to incorporate this technology into routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician led ventilator set up | No intervention | –Patients will be set up on non-invasive ventilation as per the current gold standard physician led approach |
| parasternal electromyography (EMG) set up | Experimental | Other: Surface parasternal electromyography (EMG) set upVentilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over the age of 16 years.
- Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome.
- Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of >6.0 kPa in the morning.
- Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of >6.0 kPa during the day.
- No prior domiciliary ventilation.
Key exclusion criteria (5 listed)
- Patients with other co-morbidities e.g. cancer or cardiac failure.
- Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease.
- Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation.
- Patients who have an abnormal bleeding tendency (INR or APTTr >1.4 or platelets <100).
- Patients with a psychological, social or geographical situation that would impair compliance with the project.
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 |
|---|---|---|
| Surface parasternal electromyography (EMG) set upVentilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony. | Other | parasternal electromyography (EMG) set up |
Primary outcome
Adherence with ventilation
Time frame: 3 months
Data on patient reported compliance and ventilator recorded compliance will be collected.
3 secondary outcomes
health related quality of life
Time frame: 3 month
length of hospital stay for initiation of home mechanical ventilation
Time frame: 3 months
gas exchange
Time frame: 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 3 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surface parasternal electromyography (EMG) set up in people with Chronic Hypercapnic Respiratory Failure and Obesity Hypoventilation Syndrome, run by Michelle Ramsay at 2 sites 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 5 inclusion and 5 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 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adherence with ventilation (time frame: 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 3 Apr 2014.