Non Invasive Ventilation During Physical Training in Cystic Fibrosis

Sponsor

Karolinska University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02684552

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Device: Non invasive ventilation Device: Oxygen	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Physiotherapist in Charge of the Study

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non invasive ventilation Patients perform physical test with non invasive ventilation	Device: Non invasive ventilation Training on treadmill with Non invasive ventilation
Active Comparator: Oxygen Patients perform physical test with oxygen with mask	Device: Oxygen Training on treadmill with oxygen

Arm

Intervention/Treatment

Experimental: Non invasive ventilation

Patients perform physical test with non invasive ventilation

Device: Non invasive ventilation

Training on treadmill with Non invasive ventilation

Active Comparator: Oxygen

Patients perform physical test with oxygen with mask

Device: Oxygen

Training on treadmill with oxygen

Outcome Measures

Primary Outcome Measures

Transcutaneous level carbon dioxide [10 min measurement]
Physiological parameter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maria Cecilia Rodriguez Hortal	Stockholm		Sweden	14135
2	Cecilia Rodriguez	Stockholm		Sweden	14178

Sponsors and Collaborators

Karolinska University Hospital

Investigators

Principal Investigator: Maria Cecilia Rodriguez Hortal, MSC, Karolinska University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cecilia Rodriguez, Physiotherapist, Karolinska University Hospital

ClinicalTrials.gov Identifier:

NCT02684552

Other Study ID Numbers:

2016

First Posted:

Feb 18, 2016

Last Update Posted:

Aug 30, 2016

Last Verified:

Aug 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Cystic Fibrosis

Fibrosis

Study Results

No Results Posted as of Aug 30, 2016