Clinical trial NCT02265458: Musical Intervention in Non-invasive Ventilation
Official title: Musical Intervention in the ICU: Effect on Tolerance and Acceptance of Non-invasive Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: Respiratory failure
NIV
Musical intervention
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV failure, and intubation. Music therapy has been used in various clinical context, including in ICU patients under mechanical ventilation. We aim to evaluate the effect of a musical intervention on respiratory comfort during NIV for acute respiratory failure.

Detailed description: We plan a randomized controlled trial with 3 different arms, in ICU patients requiring NIV for acute respiratory failure : "usual care", "sensory isolation" and "sensory isolation and musical intervention".At the onset of respiratory failure, each patient will be randomized in one of the 3 arms. "Usual care" assigned patients will receive NIV according to each unit protocol; "sensory isolation" assigned patients will receive NIV associated with a mask obscuring the eyes and a noise-reducing headset."musical intervention patients" will receive a 30 minutes musical intervention during each NIV session. Respiratory discomfort will be blindly assessed before, immediately after NIV is correctly set (5 minutes), at 30 minutes, and at hours 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 according to NIV session length, and at the end of NIV session during each NIV session.

Eligibility criteria: Inclusion Criteria:

* respiratory distress requiring NIV
* Glasgow coma score above 12

Exclusion Criteria:

* NIV contraindication : Hemodynamic failure, neurologic failure, head trauma, vomiting
* Severe hypoacusis people without hearing device
* Decision to limit active treatment with an estimated life expectancy of less than 48 hours

Primary outcomes:
measure: Variation of respiratory discomfort during the 30 first minutes of NIV
timeFrame: 30 minutes
Secondary outcomes:
measure: Evolution of respiratory parameters
timeFrame: participants will be followed for the duration of hospital stay or maximum 28 days
measure: Evolution of respiratory parameters
timeFrame: participants will be followed for the duration of hospital stay or maximum 28 days
measure: Evolution of respiratory parameters
timeFrame: participants will be followed for the duration of hospital stay or maximum 28 days
measure: Number of NIV failure
timeFrame: participants will be followed for the duration of hospital stay or maximum 28 days
measure: Quality of life
timeFrame: 3 months
measure: Evolution of cardiovascular parameters
timeFrame: participants will be followed for the duration of hospital stay or maximum 28 days
measure: Evolution of cardiovascular parameters
timeFrame: participants will be followed for the duration of hospital stay or maximum 28 days
measure: Post traumatic stress disorder
timeFrame: 3 months
measure: overall assessment of NIV (in terms of discomfort, satisfaction, and trauma)
timeFrame: 3 months
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: La Roche Sur Yon
country: France
facility: CHD Vendée
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: AP-HP Louis Mourier
name: Jonathan MESSIKA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guetin S, Dechanet A, Fauquembergue A, Gaudry S, Dreyfuss D, Ricard JD. Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA). Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z.