Cystic FibrosisNCT02684552
Non Invasive Ventilation During Physical Training in Cystic Fibrosis
A study testing Non invasive ventilation and Oxygen in people with Cystic Fibrosis, run by Karolinska University Hospital at 2 sites in Sweden.
Trial summary
Patients with cystic fibrosis older than 18 years will performance a Bruce test with non invasive ventilation (once) after 30 minutes they perform the same test with oxygen supplementation. Measurements: Transcutaneous level off carbon dioxide, saturation, puls and dyspnea scale. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Non invasive ventilation and Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesSweden
- Study dates
- Feb 2016to Aug 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Cystic Fibrosis at Stockholm Cystic Fibrosis center
- > 18 years of age
- Forced expiratory volume in one second (FEV1) between 20 and 69% of predicted value
- Developed alveolar hypoventilation at the physical performance test
- Use oxygen supplementation during aerobic training
Who cannot join
- Symptomatic upper airway infection characterized by fever less than 1 month before entering the study
- Cognitive dysfunction
- Cardio-respiratory instability
- Infection with Burkholderia cepacia complex
- Gastroesophageal reflux
- History of pneumothorax
- Massive hemoptysis.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Cecilia Rodriguez
Stockholm, Stockholm County, 14178
Maria Cecilia Rodriguez Hortal
Stockholm, 14135
About this study
Official title: Physiotherapist in Charge of the Study
Patients with cystic fibrosis older than 18 years will performance a Bruce test with non invasive ventilation (once) after 30 minutes they perform the same test with oxygen supplementation.
Measurements: Transcutaneous level off carbon dioxide, saturation, puls and dyspnea scale.
Read the detailed description
measurements before and after the test: transcutaneous level off carbon dioxide, saturation, respiratory rate, dyspnea scale.
- Conditions
- Cystic Fibrosis
- Being tested
- Non invasive ventilation, Oxygen
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive ventilationDevice
Training on treadmill with Non invasive ventilation
OxygenDevice
Training on treadmill with oxygen
| Study group | Role | What they receive |
|---|---|---|
| Non invasive ventilation | Experimental | Patients perform physical test with non invasive ventilation Receives: Device: Non invasive ventilation |
| Oxygen | Active comparator | Patients perform physical test with oxygen with mask Receives: Device: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcutaneous level carbon dioxide
Physiological parameter
Measured: 10 min measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2016
- Study completionAug 2016
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.
- More trials run by Karolinska University HospitalThe 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
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Rodriguez, Karolinska University Hospital
- Investigators
- Maria Cecilia Rodriguez Hortal, MSC, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684552
- Sponsor's protocol ID
- 2016
- Status last verified
- Aug 2016
- First submitted
- 12 Feb 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapist in Charge of the Study
- ClinicalTrials.gov ID
- NCT02684552
- Acronym / sponsor ID
- 2016
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Feb 2016 (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.
Patients with cystic fibrosis older than 18 years will performance a Bruce test with non invasive ventilation (once) after 30 minutes they perform the same test with oxygen supplementation.
Measurements: Transcutaneous level off carbon dioxide, saturation, puls and dyspnea scale.
Detailed description
measurements before and after the test: transcutaneous level off carbon dioxide, saturation, respiratory rate, dyspnea scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non invasive ventilation | Experimental | Device: Non invasive ventilationPatients perform physical test with non invasive ventilation |
| Oxygen | Active comparator | Device: OxygenPatients perform physical test with oxygen with mask |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with Cystic Fibrosis at Stockholm Cystic Fibrosis center
- > 18 years of age
- Forced expiratory volume in one second (FEV1) between 20 and 69% of predicted value
- Developed alveolar hypoventilation at the physical performance test
- Use oxygen supplementation during aerobic training
Key exclusion criteria (7 listed)
- Symptomatic upper airway infection characterized by fever less than 1 month before entering the study
- Cognitive dysfunction
- Cardio-respiratory instability
- Infection with Burkholderia cepacia complex
- Gastroesophageal reflux
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 |
|---|---|---|
| Non invasive ventilationTraining on treadmill with Non invasive ventilation | Device | Non invasive ventilation |
| OxygenTraining on treadmill with oxygen | Device | Oxygen |
Primary outcome
Transcutaneous level carbon dioxide
Time frame: 10 min measurement
Physiological parameter
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 30 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Maria Cecilia Rodriguez Hortal, MSC principal investigator
Karolinska University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive ventilation and Oxygen in people with Cystic Fibrosis, run by Karolinska University Hospital at 2 sites in Sweden.
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 7 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 30 Aug 2016. 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 Sweden. 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?
Transcutaneous level carbon dioxide (time frame: 10 min measurement). 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 30 Aug 2016.