Volontary Inspiratory Muscles Measures Compared With Phre... | NCT02078050

Studies
Volontary Inspiratory Muscles Measures Compared With Phrenic Nerves Magnetic Stimulations Measures

NCT02078050

Sponsor

Centre d'Investigation Clinique et Technologique 805

Status

Terminated

Last Update Posted

Jan 12, 2017Estimated

Enrollment

54Actual

Phase

Not Applicable

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

Feb 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Dec 20, 2013

First Submission Date that Met QC Criteria

Mar 3, 2014

First Posted Date

Mar 5, 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

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

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 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phrenic nerves magnetic stimulations	Other		Other: Phrenic nerves magnetic stimulations

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phrenic nerves magnetic stimulations	Other		Phrenic nerves magnetic stimulations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

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