Cystic Fibrosis
Conditions
Keywords
Lung function
Brief summary
With the use of Non invasive ventilation the patients with cystic fibrosis will have better lung function (FEV1).
Detailed description
3 months intervention between PEP an Bilevel. The patients will follow up under 3 months.
Interventions
DEVICEBilevel
3 months
DEVICEPEP mask
3 months
Sponsors
Karolinska Institutet
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with CF older than 18 years * FEV1 between 20% and 69% of predictive. * No acute exacerbation. * No Burkhordelia Cepacia/MRSA colonization.
Exclusion criteria
* Children under 18 year * acute exacerbation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Function: Lung Clearance Index | up to 3 months | Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa). | 1 month | After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bilevel Bilevel, 3 months
Bilevel: 3 months | 16 |
| PEP Mask PEP mask, 3 months
PEP mask: 3 months | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Bilevel | PEP Mask | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Continuous | 28 years STANDARD_DEVIATION 11 | 33 years STANDARD_DEVIATION 9 | 31 years STANDARD_DEVIATION 10 |
| Region of Enrollment Sweden | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Lung Function: Lung Clearance Index
Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value.
Time frame: up to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilevel | Lung Function: Lung Clearance Index | 9 lung clearance index | Standard Deviation 3 |
| PEP Mask | Lung Function: Lung Clearance Index | 9.7 lung clearance index | Standard Deviation 3 |
Secondary
Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa).
After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month.
Time frame: 1 month