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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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With the use of Non invasive ventilation the patients with cystic fibrosis will have better lung function (FEV1).
3 months intervention between PEP an Bilevel. The patients will follow up under 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilevel | Experimental | Bilevel, 3 months. The treatment was performed twice a day, 1 hour each treatment. |
|
| PEP mask | Active Comparator | PEP mask, 3 months. The treatment was performed twice a day, 1 hour each treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilevel | Device | 3 months |
| |
| PEP mask |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecilia Rodriguez, Physio | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cecilia Rodriguez | Stockholm | Stockholm County | 14178 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilevel | Bilevel, 3 months Bilevel: 3 months |
| FG001 | PEP Mask | PEP mask, 3 months PEP mask: 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bilevel | Bilevel, 3 months Bilevel: 3 months |
| BG001 | PEP Mask | PEP mask, 3 months PEP mask: 3 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | lung clearance index | up to 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bilevel | Bilevel, 3 months Bilevel: 3 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Cecilia Rodriguez Hortal | Karolinska University Hospital | 0046709558699 | cecilia.rodriguez-hortal@karolinska.se |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Device |
3 months |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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. | Not Posted | 1 month |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | PEP Mask | PEP mask, 3 months PEP mask: 3 months | 0 | 16 | 0 | 16 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D012138 |
| Respiratory Therapy |