Establishment of a Non-invasive and Indirect Measure of V... | NCT02242162

Studies
Establishment of a Non-invasive and Indirect Measure of Volitional Pimax

NCT02242162

Sponsor

Centre d'Investigation Clinique et Technologique 805

Status

Completed

Last Update Posted

Mar 2, 2016Estimated

Enrollment

75Actual

Phase

Not provided

Conditions

Neuromuscular Diseases
Respiratory Failure

Interventions

phrenic nerves magnetic stimulations

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Sep 15, 2014

First Submission Date that Met QC Criteria

Sep 15, 2014

First Posted Date

Sep 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2016

Last Update Posted Date

Mar 2, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Respiratory failure is the main death cause in muscular diseases. Non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril and the maximal inspiratory pressure (PImax).Unfortunately, volitional maneuvers depend of patient effort. The mean of this reseach is to validate a non-invasive and non-volitional technique to evaluate diaphragm strength at muscular diseases patients.The methdology consist to compar PImax measure to nerves magnetical stimulation maneuvers measure.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
neuromuscular diseases			Procedure: phrenic nerves magnetic stimulations

Interventions

Name	Type	Description	Arm Group Labels	Other Names
phrenic nerves magnetic stimulations	Procedure		neuromuscular diseases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
magnetic stimulation pressure measure( Pstim)	phrenic nerves magnetic stimulations	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Neuromuscular disease
Pimax evaluation indication

Exclusion Criteria:

pregnant women
usual contre-indications for nuclear magnetic resonance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

neuromuscular diseases

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
frederic Lofaso, Pr	Hopital R Poincaré	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital R Poincaré		Garches		92380	France

Condition Browse Module

MeSH Terms

ID	Term
D009468	Neuromuscular Diseases
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided