Relationship Between PFTs and Pdi in DMD

May 8, 2018 updated by: University of Minnesota

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Clinical diagnosis of Duchenne muscular dystrophy

Exclusion Criteria:

  • Inability to follow verbal instructions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
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.
Diagnostic test: Nasal Pressure Transducer
Pressure transducer inserted into nasal plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Pdi
Time Frame: 1 year
For all subjects Pdi (transdiaphragmatic pressure measures) will be assessed with gastric and esophageal balloons
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of SNIP
Time Frame: 1 year
For all subjects, SNIP (sniff nasal inspiratory pressures) will be assessed with a nasal pressure transducer
1 year
Evaluation of FVC
Time Frame: 1 year
For all subjects, FVC (forced vital capacity) will be assessed with spirometry
1 year
Evaluation of FEV1
Time Frame: 1 year
For all subjects, FEV1 (forced expiratory volume in 1 second) will be assessed with spirometry
1 year
Evaluation of FEFmax
Time Frame: 1 year
For all subjects, FEFmax (maximal forced expiratory flow) will be assessed with spirometry
1 year
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
1 year
Evaluation of FEF50
Time Frame: 1 year
For all subjects, FEF50 (forced expiratory flow at 50% of FVC) will be assessed with spirometry
1 year
Evaluation of MIP
Time Frame: 1 year
For all subjects, MIP (maximal inspiratory pressure) will be assessed with spirometry
1 year
Evaluation of MEP
Time Frame: 1 year
For all subjects, MEP (maximal expiratory pressure) will be assessed with spirometry
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Fairview Health Services

Investigators

  • Principal Investigator: Eric M Snyder, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

October 12, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001062

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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