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Completed

NCT Number: NCT02083263

Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis

With the use of Non invasive ventilation the patients with cystic fibrosis will have better lung function (FEV1).

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cecilia Rodriguez

Stockholm, Stockholm County, 14178, Sweden

About this study

3 months intervention between PEP an Bilevel. The patients will follow up under 3 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with CF older than 18 years
  • FEV1 between 20% and 69% of predictive.
  • No acute exacerbation.
  • No Burkhordelia Cepacia/MRSA colonization.

Exclusion criteria

  • Children under 18 year
  • acute exacerbation.

Treatment and study plan

Bilevel

Device

3 months

PEP mask

Device

3 months

Primary outcomes

  1. Lung Function: Lung Clearance Index

    Time frame: up to 3 months

    Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value.

Secondary outcomes

  1. Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa).

    Time frame: 1 month

    After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Study of Non Invasive Ventilation With High Pressure as Airways Clearance Technique in Adults Patients With Cystic Fibrosis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 11, 2014
Registry last updated
Jul 16, 2014

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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