NCT03335384

Relationship Between PFTs and Pdi in DMD

The Relationship Between Pulmonary Function Measures and Transdiaphragmatic Measures in Duchenne Muscular Dystrophy Subjects

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: Male
• Age: 6 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Esophageal Balloon	Small flexible catheter with deflated balloon at distal end to be inserted into the esophagus through the nose
DIAGNOSTIC_TEST	Gastric Balloon	Small flexible catheter with deflated balloon at distal end to be inserted into the stomach through the nose
DIAGNOSTIC_TEST	Nasal Pressure Transducer	Pressure transducer inserted into nasal plug

Timeline

• Start date: 2018-05-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2017-11-07
• Last updated: 2018-05-14

Regulatory

• FDA-regulated device study