The Relationship Between Pulmonary Function Measures and Transdiaphragmatic Measures in Duchenne Muscular Dystrophy Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Duchenne Muscular Dystrophy
- Sponsor
- University of Minnesota
- Primary Endpoint
- Evaluation of Pdi
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
A cross-sectional study to explore the relationship between clinically assessed pulmonary function test (PFT) measures and transdiaphragmatic (Pdi) measures in Duchenne muscular dystrophy (DMD) as well as to explore the relationship between sniff nasal inspiratory pressure (SNIP) and transdiaphragmatic (Pdi) measures in Duchenne muscular dystrophy.
Detailed Description
Two small balloons, which are attached to small, flexible tubes, will be put into the esophagus and stomach through your nose. Each balloon is about 2 inches long (deflated) and about the width of a pencil tip. To reduce any discomfort with this procedure, lidocaine gel or spray will be put into the subject's nose and administered to the back of the throat before the balloon. In addition, swallowing water during the procedure will help to reduce any gagging sensation and will assure that the balloon goes into the esophagus. Proper placement of the catheters will be determined using normal tidal breathing against an occluded mouthpiece with a nose clip. Once proper placement is ensured, the catheters will remain in place during your normal PFT maneuvers. Additionally, while the gastric and esophageal balloon catheters are in place, the subject will be asked to perform a maximal sniff maneuver (SNIP) while one nostril is occluded with a plug containing a distal pressure measurement catheter to measure airway pressure. The distal end of the pressure catheter will be connected to a hand held pressure meter to display peak pressure and to provide you visual feedback. This maneuver will be performed 10 times.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of Duchenne muscular dystrophy
Exclusion Criteria
- •Inability to follow verbal instructions
Outcomes
Primary Outcomes
Evaluation of Pdi
Time Frame: 1 year
For all subjects Pdi (transdiaphragmatic pressure measures) will be assessed with gastric and esophageal balloons
Secondary Outcomes
- Evaluation of SNIP(1 year)
- Evaluation of MEP(1 year)
- Evaluation of FEF50(1 year)
- Evaluation of FVC(1 year)
- Evaluation of FEF25-75(1 year)
- Evaluation of MIP(1 year)
- Evaluation of FEV1(1 year)
- Evaluation of FEFmax(1 year)