NCT02288299

Brief Summary

The long-term effect of LIAM (Lung Insufflation Assist Maneuver) on respiratory performance in home non-invasively ventilated (NIV) patients suffering from neuromuscular disease will be assessed in a prospective, randomized, cross over, open label study

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

October 29, 2015

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 18, 2019

Status Verified

February 1, 2019

Enrollment Period

6.2 years

First QC Date

November 5, 2014

Last Update Submit

November 15, 2019

Conditions

Neuromuscular Disease

Keywords

Instrumental cough assistancepositive pressure insufflation maneuverhome mechanical ventilationprospective evaluation

Outcome Measures

Primary Outcomes (1)

  • Change in the maximal assisted vital capacity (maximal insufflation capacity) between the begin of the treatment period and the 3-months follow up

    Change in the maximal assisted vital capacity (maximal insufflation capacity) between the begin of the treatment period and the 3-months follow up

    15 minutes

Secondary Outcomes (3)

  • spontaneous vital capacity

    15 minutes

  • peak flow

    15 minutes

  • optoelectronic plethysmography

    1 hour

Study Arms (1)

non invasive mechanical ventilation

EXPERIMENTAL

Patients suffering from neuromuscular disease with NIV indication and cough inefficiency

Device: non invasive mechanical ventilation

Interventions

non invasive mechanical ventilationDEVICE

instrumental increase of inspiratory capacity and cough

non invasive mechanical ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • o neuromuscular disease ( progressive muscular dystrophy, for example; Duchenne muscular dystrophy, spinal muscular atrophy)
  • age ≥ 18 years
  • indication to NIV (ongoing ventilation or new patients)
  • vital capacity ≤ 50% pred
  • peak cough flow \< 270 l/min
  • "LIAM Responder" = increased insufflation capacity (≥ + 50%) and Peak Cough Flow (PCF ≥+ 50%) with LIAM

You may not qualify if:

  • o acute respiratory failure (respiratory acidosis)
  • home treatment by instrumental cough assistance in the preceding 12 months
  • ongoing medical treatment of the neuromuscular disease (for ex: corticosteroids in Duchenne disease, enzyme therapy in Pompe disease)
  • previous pneumothorax
  • plan of legal protection
  • pregnant or breastfeeding women
  • failure to cooperate
  • no affiliation to a social security scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Home ventilation Unit , Raymond Poincaré hospital

Garches, Paris Area, 92380, France

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • David Orlikowski, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Orlikowski, MD, PhD

CONTACT

+33(0)147107777david.orlikowski@rpc.aphp.fr

Frederic Lofaso, MD, PhD

CONTACT

+33(0)147107941frederic.lofaso@rpc.aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 11, 2014

Study Start

October 29, 2015

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 18, 2019

Record last verified: 2019-02

Locations

FR(1)