Non Invasive Ventilation During Physical Training in Cystic Fibrosis

Karolinska University Hospital

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Device: Non invasive ventilation; Device: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02684552

2016

Details and patient eligibility

About

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.

Full description

measurements before and after the test: transcutaneous level off carbon dioxide, saturation, respiratory rate, dyspnea scale.

Enrollment: 8 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

8 participants in 2 patient groups

Non invasive ventilation

Experimental group

Description:

Patients perform physical test with non invasive ventilation

Treatment:

Device: Non invasive ventilation

Oxygen

Active Comparator group

Description:

Patients perform physical test with oxygen with mask

Treatment:

Device: Oxygen