Optimizing Communication During Ventilation

Respiratory Failure Clinical Trial

— PHONOVNI  

Official title:

Optimizing Communication During Nasal Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819090
• Other study ID #: 2012- A01394-39
• Status: Completed
• Phase: N/A
• First received: March 7, 2013
• Last updated: February 12, 2016
• Start date: November 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neuromuscular Diseases
• Neuromuscular Disorder
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Elysee 150 ventilator

• Elysee 150 ventilator with a ventilation switch control

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	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	Impact of patient's ventilation control on speech efficiency	Speech efficiency will be evaluated while using a ventilator which allows the patient to constantly control when he wants to be ventilated Speech evaluation is based on speech rhythm and text reading duration	1 hour 30 min	No
Secondary	Patient ventilator synchronisation during speech	Evaluated with the variation of respiratory frequency during speech, the number of auto-triggered ventilation cycles during speech.	1hour 30 min	No
Secondary	User friendliness of the ventilator during speech	evaluation of user friendliness by the patient using a visual analogical score	1hour 30 min	No
Secondary	Respiratory comfort during speech	evaluation of user friendliness by the patient using a visual analogical score and the Borg score	1hour 30 min	No
Secondary	Speech comfort during ventilation	evaluation of speech comfort during ventilation by the patient using a visual analogical score	1hour 30 min	No