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Volontary Inspiratory Muscles Measures Compared With Phrenic Nerves Magnetic Stimulations Measures

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre d'Investigation Clinique et Technologique 805
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT02078050
First received: December 20, 2013
Last updated: March 3, 2014
Last verified: March 2014
  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: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Phrenic nerves magnetic stimulations Other: Phrenic nerves magnetic stimulations

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02078050

Contacts
Contact: Frédéric Lofaso, Pr +3310147107941 f.lofaso@rpc.aphp.fr

Locations
France
Hopital R. Poincaré Recruiting
Garches, France, 92380
Contact: Frédéric Lofaso, Pr    +3310147107941    f.lofaso@rpc.aphp.fr   
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
  More Information

No publications provided

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02078050     History of Changes
Other Study ID Numbers: 2013-A00638-37
Study First Received: December 20, 2013
Last Updated: March 3, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

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

ClinicalTrials.gov processed this record on November 27, 2014