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NCT02078050 Clinical Trial

Volontary Inspiratory Muscles Measures Compared With Phrenic Nerves Magnetic Stimulations Measures

Respiratory Failure Clinical Trial

Official title:
Volontary Inspiratory Muscles Measures Compared With Phrenic Nerves Magnetic Stimulations Measures

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02078050
Other study ID # 2013-A00638-37
Secondary ID
Status Terminated
Phase N/A
First received December 20, 2013
Last updated January 11, 2017
Start date November 2013
Est. completion date May 2015

Study information
Verified date February 2016
Source Centre d'Investigation Clinique et Technologique 805
Contact n/a
Is FDA regulated No
Health authority France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Terminated
Enrollment 54
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Other:
• Phrenic nerves magnetic stimulations

Locations
Country Name City State
France Hopital R. Poincaré Garches

Sponsors (1)
Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 10 minutes No
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