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OpenTrials
Completed

NCT Number: NCT02684552

Non Invasive Ventilation During Physical Training in Cystic Fibrosis

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.

Completed

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cecilia Rodriguez, Stockholm, Stockholm County, Sweden

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non invasive ventilation

Device

Training on treadmill with Non invasive ventilation

Oxygen

Device

Training on treadmill with oxygen

Primary outcomes

  1. Transcutaneous level carbon dioxide

    Time frame: 10 min measurement

    Physiological parameter

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

Physiotherapist in Charge of the Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2016
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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