Optimizing Communication During Ventilation

NCT ID: NCT01819090

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-03-31

Brief Summary

Mechanical ventilation is one of the only treatment that has improved survival of patients with neuromuscular respiratory failure. As disease progresses, some patients may require longer ventilation period. Non invasive mechanical ventilation is the preferred method of ventilation but it may interfere with speech and communication of patients who require ventilation throughout the day. The investigators are evaluating the effect on speech and communication of a ventilation device which allows patients to momentarily and voluntarily withhold ventilation if they want to speak. This should allow the patients to have a more fluid speech.

Conditions

Neuromuscular Disorder; Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

No ventilation switch control

Neuromuscular patients non invasively ventilated in a stable state at the time of the study testing an usual (with no ventilation switch control) Elysee 150 ventilator while speaking

Group Type: ACTIVE_COMPARATOR

Elysee 150 ventilator

Intervention Type: DEVICE

Ventilation switch control

Neuromuscular patients non invasively ventilated in a stable state at the time of the study testing an Elysee 150 ventilator with a ventilation switch control allowing them to control ventilation while speaking

Group Type: ACTIVE_COMPARATOR

Elysee 150 ventilator with a ventilation switch control

Intervention Type: DEVICE

Interventions

Elysee 150 ventilator

Intervention Type: DEVICE

Elysee 150 ventilator with a ventilation switch control

Intervention Type: DEVICE

Other Intervention Names

Elysee 150 - Resmed; Elysee 150 ventilator - Resmed - with a ventilation switch control

Eligibility Criteria

Inclusion Criteria

• Patient with restrictive respiratory failure secondary to a neuromuscular disorder, without any bulbar involvement.
• Age greater than or equal to 18.
• Hospitalization in Home Ventilation Unit of the intensive care department of R. Poincaré Hospital.
• Non invasive mechanical ventilation for a duration equal or above 14h per day.
• Patient in a steady state at the time of the study
• written informed consent

Exclusion Criteria

• patient's refusal to participate to the study
• Inability to read the selected text
• Inability to use the ventilator switch
• Inability to cooperate
• Hemodynamic instability
• Acute respiratory failure
• No affiliation to social security

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role: lead

Responsible Party

Helene Prigent

MDPHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helene PRIGENT, MDPHD

Role: PRINCIPAL_INVESTIGATOR

Hôpital RAYMOND POINCARE

Locations

Hopital Raymond Poincare

Garches, Garches, France

Countries

France

Other Identifiers

2012- A01394-39

Identifier Type: -

Identifier Source: org_study_id