Non Invasive Ventilation During Physical Training in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Physiotherapist in Charge of the Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684552
• Other study ID #: 2016
• Status: Completed
• Phase: N/A
• First received: February 12, 2016
• Last updated: August 29, 2016
• Start date: February 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Non invasive ventilation
Training on treadmill with Non invasive ventilation
• Oxygen
Training on treadmill with oxygen

Locations

Country	Name	City	State
Sweden	Cecilia Rodriguez	Stockholm
Sweden	Maria Cecilia Rodriguez Hortal	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcutaneous level carbon dioxide	Physiological parameter	10 min measurement	Yes