Non Invasive Ventilation During Physical Training in Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: Oxygen; Device: Non invasive ventilation

• Registration Number: NCT02684552
• Lead Sponsor: Karolinska University Hospital

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-18
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxygen	Oxygen	Patients perform physical test with oxygen with mask
Non invasive ventilation	Non invasive ventilation	Patients perform physical test with non invasive ventilation

Primary Outcome Measures

Name	Time	Method
Transcutaneous level carbon dioxide	10 min measurement	Physiological parameter

Trial Locations

Locations (2)

Maria Cecilia Rodriguez Hortal; 🇸🇪 Stockholm, Sweden

Cecilia Rodriguez; 🇸🇪 Stockholm, Sweden