Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Relationship Between PFTs and Pdi in DMD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335384
Recruitment Status : Withdrawn (Study not approved)
First Posted : November 7, 2017
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Fairview Health Services
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE October 12, 2017
First Posted Date  ICMJE November 7, 2017
Last Update Posted Date May 14, 2018
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2017)
Evaluation of Pdi [ Time Frame: 1 year ]
For all subjects Pdi (transdiaphragmatic pressure measures) will be assessed with gastric and esophageal balloons
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2017)
  • Evaluation of SNIP [ Time Frame: 1 year ]
    For all subjects, SNIP (sniff nasal inspiratory pressures) will be assessed with a nasal pressure transducer
  • Evaluation of FVC [ Time Frame: 1 year ]
    For all subjects, FVC (forced vital capacity) will be assessed with spirometry
  • Evaluation of FEV1 [ Time Frame: 1 year ]
    For all subjects, FEV1 (forced expiratory volume in 1 second) will be assessed with spirometry
  • Evaluation of FEFmax [ Time Frame: 1 year ]
    For all subjects, FEFmax (maximal forced expiratory flow) will be assessed with spirometry
  • Evaluation of FEF25-75 [ Time Frame: 1 year ]
    For all subjects, FEF25-75 (the average forced expiratory flow during the mid (25 - 75%) portion of the FVC) will be assessed with spirometry
  • Evaluation of FEF50 [ Time Frame: 1 year ]
    For all subjects, FEF50 (forced expiratory flow at 50% of FVC) will be assessed with spirometry
  • Evaluation of MIP [ Time Frame: 1 year ]
    For all subjects, MIP (maximal inspiratory pressure) will be assessed with spirometry
  • Evaluation of MEP [ Time Frame: 1 year ]
    For all subjects, MEP (maximal expiratory pressure) will be assessed with spirometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relationship Between PFTs and Pdi in DMD
Official Title  ICMJE The Relationship Between Pulmonary Function Measures and Transdiaphragmatic Measures in Duchenne Muscular Dystrophy Subjects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Cross-sectional
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Duchenne Muscular Dystrophy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Measurement of Pdi
    Two small balloons, which are attached to small, flexible tubes, will be put into the esophagus (food tube) and stomach through the nose. Each balloon is about 2 inches long (deflated) and about the width of a pencil tip. A gastric balloon will be inserted into subject's stomach while an esophageal balloon will be inserted into the subject's esophagus. 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.
    Interventions:
    • Diagnostic Test: Esophageal Balloon
    • Diagnostic Test: Gastric Balloon
  • Experimental: Measurement of SNIPs
    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 nasal pressure transducer to measure airway pressure during maximal inspiration. 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.
    Intervention: Diagnostic Test: Nasal Pressure Transducer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 8, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2017)
35
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of Duchenne muscular dystrophy

Exclusion Criteria:

  • Inability to follow verbal instructions
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 6 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03335384
Other Study ID Numbers  ICMJE STUDY00001062
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Fairview Health Services
Investigators  ICMJE
Principal Investigator: Eric M Snyder, PhD University of Minnesota
PRS Account University of Minnesota
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP