NCT02684552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

6 months

First QC Date

February 12, 2016

Last Update Submit

August 29, 2016

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Transcutaneous level carbon dioxide

    Physiological parameter

    10 min measurement

Study Arms (2)

Non invasive ventilation

EXPERIMENTAL

Patients perform physical test with non invasive ventilation

Device: Non invasive ventilation

Oxygen

ACTIVE COMPARATOR

Patients perform physical test with oxygen with mask

Device: Oxygen

Interventions

Non invasive ventilationDEVICE

Training on treadmill with Non invasive ventilation

Non invasive ventilation
OxygenDEVICE

Training on treadmill with oxygen

Oxygen

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cecilia Rodriguez

Stockholm, Stockholm County, 14178, Sweden

Location

Maria Cecilia Rodriguez Hortal

Stockholm, 14135, Sweden

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Noninvasive VentilationOxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Maria Cecilia Rodriguez Hortal, MSC

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

February 12, 2016

First Posted

February 18, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)