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-IRAReportar como inadecuado




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 - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 17:450

First Online: 13 September 2016Received: 17 December 2015Accepted: 26 August 2016DOI: 10.1186-s13063-016-1574-z

Cite this article as: Messika, J., Hajage, D., Panneckoucke, N. et al. Trials 2016 17: 450. doi:10.1186-s13063-016-1574-z

Abstract

BackgroundNon-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.

Methods-designWe 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.

DiscussionAs 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.

Trial registrationClinicalTrials.gov: NCT02265458. Registered on 25 August 2014.

KeywordsNon-invasive ventilation Critical care Music intervention Respiratory comfort AbbreviationsARFAcute respiratory failure

CCTIRSComité Consultatif sur le Traitement de l-Information en matière de Recherche dans le domaine de la Santé

CE SRLFCommission d’Ethique de la Société de Reanimation de Langue Française

CNILCommission Nationale de l-Informatique et des Libertés

eCRFElectronic case report form

FiO2Fraction of inspired oxygen

HADSHospital Anxiety and Depression Scale

IES-RImpact of Event Scale - Revised

ICUIntensive care unit

NIVNon-invasive ventilation

PaO2Arterial oxygen partial pressure

PHRIPProgramme Hospitalier de Recherche Infirmière et Paramédicale

SAPSSimplified Acute Physiology Score

SF-36Short Form-36

SOFASequential Organ Failure Assessment

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1574-z contains supplementary material, which is available to authorized users.





Autor: Jonathan Messika - David Hajage - Nataly Panneckoucke - Serge Villard - Yolaine Martin - Emilie Renard - Annie Blivet - Jea

Fuente: https://link.springer.com/







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