Non Invasive Ventilation During Physical Training in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 September 2016
• Main ID: NCT02684552
• Date of registration: 12/02/2016
• Prospective Registration: No
• Primary sponsor: Karolinska University Hospital
• Public title: Non Invasive Ventilation During Physical Training in Cystic Fibrosis
• Scientific title: Physiotherapist in Charge of the Study
• Date of first enrolment: February 2016
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02684552
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Maria Cecilia Rodriguez Hortal, MSC
• Affiliation: Karolinska University Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Device: Oxygen

Device: Non invasive ventilation

Primary Outcome(s)

Transcutaneous level carbon dioxide [Time Frame: 10 min measurement]

Secondary ID(s)

2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors