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).
Non-invasive ventilation (NIV) tolerance is a key factor of NIV success. Hence, numerous sedative pharmacological or non-pharmacological strategies have been assessed to improve NIV tolerance. Music therapy in various health care settings has shown beneficial effects. In invasively ventilated critical care patients, encouraging results of music therapy on physiological parameters, anxiety, and agitation have been reported. We hypothesize that a musical intervention improves NIV tolerance in comparison to conventional care. We therefore question the potential benefit of a receptive music session administered to patients by trained caregivers ("musical intervention") to enhance acceptance and tolerance of NIV.



We conduct a prospective, three-center, open-label, three-arm randomized trial involving patients in the intensive care unit (ICU) who require NIV, as assessed by the treating physician. Participants are allocated to a "musical intervention" arm ("musical intervention" applied during all NIV sessions), to a "sensory deprivation" arm (sight and hearing isolation during all NIV sessions), or to the control group. The primary endpoint is the change in respiratory comfort (measured with a digital visual scale) before the initiation and after 30 minutes of the first NIV session. The evaluation of the primary endpoint is performed blindly from the treatment group. Secondary endpoints include changes in respiratory and cardiovascular parameters during NIV sessions, the percentage of patients requiring endotracheal intubation, day-90 anxiety/depression and health-related quality of life, post-trauma stress induced by NIV, and the overall assessment of NIV. The follow-up for each participant is 90 days. We expect to randomize a total of 99 participants.



As music intervention is a simple and easy-to-implement non-pharmacological technique, efficacious in reducing anxiety in critically ill patients, it appeared logical to assess its efficacy in NIV, one of the most stressful techniques used in the ICU. Patient centeredness was crucial in choosing the outcomes assessed.



ClinicalTrials.gov: NCT02265458 . Registered on 25 August 2014.
AP-HP, Hôpital Louis Mourier, Réanimation Médico-chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France. jonathan.messika@aphp.fr.|Université Paris Diderot, Sorbonne Paris Cité, IAME, UMRS 1137, F-75018, Paris, France. jonathan.messika@aphp.fr.|INSERM, IAME, U1137, F-75018, Paris, France. jonathan.messika@aphp.fr.|Present address: Réanimation Médico-chirurgicale, Hôpital Louis Mourier, 178 rue des Renouillers, F-92700, Colombes, France. jonathan.messika@aphp.fr.
Jonathan
0000-0003-2123-3527
J
Messika
Université Paris Diderot, Sorbonne Paris Cité, ECEVE, UMRS 1123, F-75010, Paris, France.|INSERM, ECEVE, U1123, F-75010, Paris, France.|INSERM, CIC-EC 1425, UMR 1123, F-75010, Paris, France.
David
D
Hajage
AP-HP, Hôpital Louis Mourier, Réanimation Médico-chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France.
Nataly
N
Panneckoucke
AP-HP, Hôpital Louis Mourier, Réanimation Médico-chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France.
Serge
S
Villard
AP-HP, Hôpital Louis Mourier, Réanimation Médico-chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France.
Yolaine
Y
Martin
AP-HP, Hôpital Louis Mourier, Réanimation Médico-chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France.
Emilie
E
Renard
AP-HP, Hôpital Louis Mourier, Réanimation Médico-chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France.
Annie
A
Blivet
Centre Hospitalier Départemental de Vendée, Réanimation Médico-Chirurgicale, La Roche-sur-Yon, F-85925 Cedex 9, France.
Jean
J
Reignier
Centre Hospitalier Départemental de Vendée, Réanimation Médico-Chirurgicale, La Roche-sur-Yon, F-85925 Cedex 9, France.
Natacha
N
Maquigneau
Institut Gustave Roussy, Réanimation Médico-chirurgicale, Villejuif, F-94800, France.
Annabelle
A
Stoclin
Institut Gustave Roussy, Réanimation Médico-chirurgicale, Villejuif, F-94800, France.
Christelle
C
Puechberty
CHRU de Montpellier, Service de Neurologie, Inserm U1061, Montpellier, F-34000, France.
Stéphane
S
Guétin
INSERM, CIC-EC 1425, UMR 1123, F-75010, Paris, France.|APHP, Hôpital Louis Mourier, Département d'Epidémiologie et Recherche Clinique, 178 Rue des Renouillers, Colombes, F-92700, France.|Université Paris Diderot, UMR 1123, Sorbonne Paris Cité, Paris, France.
Aline
A
Dechanet
INSERM, CIC-EC 1425, UMR 1123, F-75010, Paris, France.|APHP, Hôpital Louis Mourier, Département d'Epidémiologie et Recherche Clinique, 178 Rue des Renouillers, Colombes, F-92700, France.|Université Paris Diderot, UMR 1123, Sorbonne Paris Cité, Paris, France.
Amandine
A
Fauquembergue
AP-HP, Hôpital Louis Mourier, Réanimation Médico-chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France.|Université Paris Diderot, Sorbonne Paris Cité, ECEVE, UMRS 1123, F-75010, Paris, France.|INSERM, ECEVE, U1123, F-75010, Paris, France.
Stéphane
S
Gaudry
AP-HP, Hôpital Louis Mourier, Réanimation Médico-chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France.|Université Paris Diderot, Sorbonne Paris Cité, IAME, UMRS 1137, F-75018, Paris, France.|INSERM, IAME, U1137, F-75018, Paris, France.
Didier
D
Dreyfuss
AP-HP, Hôpital Louis Mourier, Réanimation Médico-chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France.|Université Paris Diderot, Sorbonne Paris Cité, IAME, UMRS 1137, F-75018, Paris, France.|INSERM, IAME, U1137, F-75018, Paris, France.
Jean-Damien
JD
Ricard
D000328:Adult; D002985:Clinical Protocols; D006801:Humans; D007362:Intensive Care Units; D009147:Music Therapy; D063087:Noninvasive Ventilation; D018802:Patient-Centered Care; D011446:Prospective Studies
Critical care; Music intervention; Non-invasive ventilation; Respiratory comfort