Cystic FibrosisNIVinCFNCT02234401
Non Invasive Ventilation for Acute Exacerbations in Adult CF
A study testing Bi level pressure support in people with Cystic Fibrosis and Respiratory Failure, run by Manchester Metropolitan University at 1 site in United Kingdom.
Trial summary
Cystic Fibrosis (CF) is a life limiting illness. Median predicted UK survival is 41.4 years (UK CF Registry 2011). The commonest cause of death is respiratory failure. Non invasive ventilation (NIV) is a system which delivers a preset pressure to supplement the size and depth of each breath. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Respiratory Failure
- What is being tested?
- Bi level pressure support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Sep 2017
- 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
- Adult Cystic Fibrosis
- Hospital admission to Pearce Ward Manchester Adult Cystic Fibrosis Centre
- Acute respiratory exacerbation conforming with a standard definition of pulmonary exacerbation (Fuchs et al 1994).
- An admission day time CO2 > 6 kilopascal (kPa) on standard therapy
- Freely given informed consent.-
- 24.3.15 substantial amendment approval for an admission early morning CO2 > 6 kPa
Who cannot join
- A day time CO2 >8.0 kPa
- respiratory acidosis
- clinical exclusion by CF consultant physician or clinical psychologist
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
Wythenshawe, Manchester, M23 9LT
Susan C Johnson, MSc MCSP
About this study
Official title: A Mixed Methods Study Comparing the Clinical Efficacy With the Patient Experience of Non-invasive Ventilation During an Acute Exacerbation Complicated by Respiratory Failure in Adult Cystic Fibrosis
Cystic Fibrosis (CF) is a life limiting illness. Median predicted UK survival is 41.4 years (UK CF Registry 2011). The commonest cause of death is respiratory failure.
Non invasive ventilation (NIV) is a system which delivers a preset pressure to supplement the size and depth of each breath. It is introduced in CF to manage established respiratory failure. A nose or a mask which covers both the nose and mouth allows flexible ventilation, is used just at night, or for part of the day in addition or for 24 hours as clinical status indicates. It is introduced within a normal ward environment and then continued longterm at home.Once respiratory failure is established longterm noninvasive ventilation is introduced throughout 24 hours and multidisciplinary assessment concludes that the timing is appropriate for the individual.
Read more
This study aims to evaluate a potential development of current practice: the use of non invasive ventilation during hospital admission only to enhance recovery from an acute exacerbation which has caused respiratory failure in those individuals where long term non invasive ventilation is not yet indicated. A mixed methods design will allow description of the experience of noninvasive ventilation during a semistructured interview to add to understanding of the results from an experiment designed to measure the differences between noninvasive ventilation and standard care.
Aim: To compare the clinical efficacy with the patient experience of NIV on recovery from an acute respiratory exacerbation complicated by respiratory failure in adult Cystic Fibrosis.
Read the detailed description
Design: The study will use a mixed methodology and it will be in 2 phases. Phase I A group randomised controlled trial
The following measurements will be performed on days 1, 3, 7, 10, 14 and twice weekly until discharge:
The exact timing of measurements will be planned by the participant and the researcher.
All of the outcome measures form part of routine clinical practice except the symptom score; the Cystic Fibrosis Respiratory Symptoms Diary (CFRSD V2.0) (Goss et al., 2009)
- Early morning and day time carbon dioxide (CO2) level.
- Day time oxygen levels
- Lung function Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC)
- Day time resting Respiratory Rate (RR), Heart Rate (HR)
- Symptom score CFRSD
Phase II A qualitative exploration of the experience of using NIV for adults with Cystic Fibrosis during an acute exacerbation
Methods: Prior to discharge a semistructured interview designed to explore the experience of using noninvasive ventilation will be undertaken by a clinical psychologist from the Cystic Fibrosis multidisciplinary team. The interviews will be undertaken purely for the research project, recorded and transcribed verbatim by the lead investigator. Thematic analysis will be undertaken to interpret and explore the individual's experience. Credibility checking of interpretation will be undertaken by the clinical psychologists and within academic supervision sessions.
- Conditions
- Cystic Fibrosis, Respiratory Failure
- Being tested
- Bi level pressure support, Standard Care
- Keywords
- Cystic Fibrosis, Noninvasive ventilation, Non invasive ventilation, Acute respiratory exacerbation, Bi level pressure support
- Medical subject headings
- Cystic Fibrosis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi level pressure supportDevice
Also called Noninvasive ventilation, NIV
Standard CareOther
| Study group | Role | What they receive |
|---|---|---|
| Non invasive ventilation (NIV) | Experimental | Non invasive ventilation used for the first 7 days of study Receives: Device: Bi level pressure support |
| Standard Care | Active comparator | High Flow Controlled Oxygen Therapy Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in day time carbon dioxide (CO2)
Measured: Day 7
Secondary outcomes (5)
Early morning oxygen (O2) and CO2 levels
Measured: days 1,3,5,7,10 and 14
Lung function (FEV1 and FVC)
Measured: Day 7, 14
Respiratory Rate
Measured: days 1,3,5,7,10 and 14
Heart Rate
Measured: Days 1,3,5,7,10 and 14
Symptom score (CFRSD)
Cystic Fibrosis Respiratory Symptom Diary (Daily Recall)
Measured: days 1,3,5,7,10 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Principal investigator, Susan C Johnson, Manchester Metropolitan University
- Investigators
- Susan C Johnson, MSC MCSP, Principal investigator, Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234401
- Sponsor's protocol ID
- 1199
- Acronym
- NIVinCF
- Status last verified
- Mar 2017
- First submitted
- 5 Sep 2014
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Study Comparing the Clinical Efficacy With the Patient Experience of Non-invasive Ventilation During an Acute Exacerbation Complicated by Respiratory Failure in Adult Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02234401
- Acronym / sponsor ID
- NIVinCF / 1199
- Conditions
- Cystic Fibrosis, Respiratory Failure
- Keywords
- Cystic Fibrosis, Noninvasive ventilation, Non invasive ventilation, Acute respiratory exacerbation, Bi level pressure support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- Aug 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 9 Sep 2014 (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.
Cystic Fibrosis (CF) is a life limiting illness. Median predicted UK survival is 41.4 years (UK CF Registry 2011). The commonest cause of death is respiratory failure.
Non invasive ventilation (NIV) is a system which delivers a preset pressure to supplement the size and depth of each breath. It is introduced in CF to manage established respiratory failure. A nose or a mask which covers both the nose and mouth allows flexible ventilation, is used just at night, or for part of the day in addition or for 24 hours as clinical status indicates. It is introduced within a normal ward environment and then continued longterm at home.Once respiratory failure is established longterm noninvasive ventilation is introduced throughout 24 hours and multidisciplinary assessment concludes that the timing is appropriate for the individual.
This study aims to evaluate a potential development of current practice: the use of non invasive ventilation during hospital admission only to enhance recovery from an acute exacerbation which has caused respiratory failure in those individuals where long term non invasive ventilation is not yet indicated. A mixed methods design will allow description of the experience of noninvasive ventilation during a semistructured interview to add to understanding of the results from an experiment designed to measure the differences between noninvasive ventilation and standard care.
Aim: To compare the clinical efficacy with the patient experience of NIV on recovery from an acute respiratory exacerbation complicated by respiratory failure in adult Cystic Fibrosis.
Detailed description
Design: The study will use a mixed methodology and it will be in 2 phases. Phase I A group randomised controlled trial
The following measurements will be performed on days 1, 3, 7, 10, 14 and twice weekly until discharge:
The exact timing of measurements will be planned by the participant and the researcher.
All of the outcome measures form part of routine clinical practice except the symptom score; the Cystic Fibrosis Respiratory Symptoms Diary (CFRSD V2.0) (Goss et al., 2009)
- Early morning and day time carbon dioxide (CO2) level.
- Day time oxygen levels
- Lung function Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC)
- Day time resting Respiratory Rate (RR), Heart Rate (HR)
- Symptom score CFRSD
Phase II A qualitative exploration of the experience of using NIV for adults with Cystic Fibrosis during an acute exacerbation
Methods: Prior to discharge a semistructured interview designed to explore the experience of using noninvasive ventilation will be undertaken by a clinical psychologist from the Cystic Fibrosis multidisciplinary team. The interviews will be undertaken purely for the research project, recorded and transcribed verbatim by the lead investigator. Thematic analysis will be undertaken to interpret and explore the individual's experience. Credibility checking of interpretation will be undertaken by the clinical psychologists and within academic supervision sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non invasive ventilation (NIV) | Experimental | Device: Bi level pressure supportNon invasive ventilation used for the first 7 days of study |
| Standard Care | Active comparator | Other: Standard CareHigh Flow Controlled Oxygen Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult Cystic Fibrosis
- Hospital admission to Pearce Ward Manchester Adult Cystic Fibrosis Centre
- Acute respiratory exacerbation conforming with a standard definition of pulmonary exacerbation (Fuchs et al 1994).
- An admission day time CO2 > 6 kilopascal (kPa) on standard therapy
- Freely given informed consent.-
Key exclusion criteria (3 listed)
- A day time CO2 >8.0 kPa
- respiratory acidosis
- clinical exclusion by CF consultant physician or clinical psychologist
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 |
|---|---|---|
| Bi level pressure supportAlso: Noninvasive ventilation, NIV | Device | Non invasive ventilation (NIV) |
| Standard Care | Other | Standard Care |
Primary outcome
Change in day time carbon dioxide (CO2)
Time frame: Day 7
5 secondary outcomes
Early morning oxygen (O2) and CO2 levels
Time frame: days 1,3,5,7,10 and 14
Lung function (FEV1 and FVC)
Time frame: Day 7, 14
Respiratory Rate
Time frame: days 1,3,5,7,10 and 14
Heart Rate
Time frame: Days 1,3,5,7,10 and 14
Symptom score (CFRSD)
Time frame: days 1,3,5,7,10 and 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
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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.
Susan C Johnson, MSC MCSP principal investigator
Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi level pressure support in people with Cystic Fibrosis and Respiratory Failure, run by Manchester Metropolitan University 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 6 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 22 Mar 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan C Johnson, MSc MCSP (0161291 ext. 5007, susan.johnson@uhsm.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in day time carbon dioxide (CO2) (time frame: Day 7). 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 22 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.