Non Invasive Ventilation During Physical Training in Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non invasive ventilation

Patients perform physical test with non invasive ventilation

Group Type EXPERIMENTAL

Non invasive ventilation

Intervention Type DEVICE

Training on treadmill with Non invasive ventilation

Oxygen

Patients perform physical test with oxygen with mask

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type DEVICE

Training on treadmill with oxygen

Interventions

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Non invasive ventilation

Training on treadmill with Non invasive ventilation

Intervention Type DEVICE

Oxygen

Training on treadmill with oxygen

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No