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Volontary Inspiratory Muscles Measures Compared With Phrenic Nerves Magnetic Stimulations Measures

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02078050
First Posted: March 5, 2014
Last Update Posted: January 12, 2017
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.
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805
  Purpose
Respiratory failure is the main death cause in neuromuscular diseases. Non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril (Psnip) and the maximal inspiratory pressure (PImax). Unfortunately, volitional maneuvers depend of patient effort. The aim of this research is to validate a non-invasive and non-volitional technique to evaluate diaphragm strength at neuromuscular diseases patients. The methodology consists to add to PImax and Psnip measures 5 phrenic nerves magnetical stimulation maneuvers (Pstim).Stimulations will be realize at 3 inspiratory pression levels (0, -1 cm H2O and -5 cm H2O).

Condition Intervention
Neuromuscular Diseases Respiratory Failure Other: Phrenic nerves magnetic stimulations

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Volontary Inspiratory Muscles Measures Compared With Phrenic Nerves Magnetic Stimulations Measures

Resource links provided by NLM:


Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • Magnetic stimulation pressure measure (Pstim), according to 3 conditions : Pstime, Pstim-5 and Pstim-1 (measured in cmH20). The condition which is most correlated with maximal inspiratory pressure (Pimax or Psnip) is selected. [ Time Frame: 10 minutes ]

Enrollment: 54
Study Start Date: November 2013
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Phrenic nerves magnetic stimulations Other: Phrenic nerves magnetic stimulations

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old and more men or women
  • neuromuscular diseases
  • Pimax and Snip evaluation Indication

Exclusion Criteria:

  • pregnant women
  • Usual contre-indications for nuclear magnetic resonance
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078050


Locations
France
Hopital R. Poincaré
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
  More Information

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02078050     History of Changes
Other Study ID Numbers: 2013-A00638-37
First Submitted: December 20, 2013
First Posted: March 5, 2014
Last Update Posted: January 12, 2017
Last Verified: February 2016

Additional relevant MeSH terms:
Respiratory Insufficiency
Neuromuscular Diseases
Respiration Disorders
Respiratory Tract Diseases
Nervous System Diseases