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Non Invasive Ventilation During Physical Training in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Non invasive ventilation
Oxygen
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maria Cecilia Rodriguez Hortal
  • Cecilia Rodriguez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non invasive ventilation

Oxygen

Arm Description

Patients perform physical test with non invasive ventilation

Patients perform physical test with oxygen with mask

Outcomes

Primary Outcome Measures

Transcutaneous level carbon dioxide
Physiological parameter

Secondary Outcome Measures

Full Information

First Posted
February 12, 2016
Last Updated
August 29, 2016
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02684552
Brief Title
Non Invasive Ventilation During Physical Training in Cystic Fibrosis
Official Title
Physiotherapist in Charge of the Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non invasive ventilation
Arm Type
Experimental
Arm Description
Patients perform physical test with non invasive ventilation
Arm Title
Oxygen
Arm Type
Active Comparator
Arm Description
Patients perform physical test with oxygen with mask
Intervention Type
Device
Intervention Name(s)
Non invasive ventilation
Intervention Description
Training on treadmill with Non invasive ventilation
Intervention Type
Device
Intervention Name(s)
Oxygen
Intervention Description
Training on treadmill with oxygen
Primary Outcome Measure Information:
Title
Transcutaneous level carbon dioxide
Description
Physiological parameter
Time Frame
10 min measurement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Cecilia Rodriguez Hortal, MSC
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Cecilia Rodriguez Hortal
City
Stockholm
ZIP/Postal Code
14135
Country
Sweden
Facility Name
Cecilia Rodriguez
City
Stockholm
ZIP/Postal Code
14178
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Non Invasive Ventilation During Physical Training in Cystic Fibrosis

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