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)

Jonathan Messika, David Hajage, Nataly Panneckoucke, Serge Villard, Yolaine Martin, Emilie Renard, Annie Blivet, Jean Reignier, Natacha Maquigneau, Annabelle Stoclin, Christelle Puechberty, Stéphane Guétin, Aline Dechanet, Amandine Fauquembergue, Stéphane Gaudry, Didier Dreyfuss, Jean-Damien Ricard, Jonathan Messika, David Hajage, Nataly Panneckoucke, Serge Villard, Yolaine Martin, Emilie Renard, Annie Blivet, Jean Reignier, Natacha Maquigneau, Annabelle Stoclin, Christelle Puechberty, Stéphane Guétin, Aline Dechanet, Amandine Fauquembergue, Stéphane Gaudry, Didier Dreyfuss, Jean-Damien Ricard

Abstract

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov: NCT02265458 . Registered on 25 August 2014.

Keywords: Critical care; Music intervention; Non-invasive ventilation; Respiratory comfort.

Figures

Fig. 1
Fig. 1
Study protocol and randomization arms. Pressure support is progressively increased in order to obtain a respiratory rate between 15 and 25 cycles per minute, an exhaled tidal volume of 6–10 ml/kg of predicted body weight, and the disappearance of signs of respiratory distress. Positive end expiratory pressure is set 2–6 cm H2O above pressure support and adjusted according to patient’s tolerance. FiO2 is set to obtain a minimal pulse oximetry of 92 %. NIV non-invasive ventilation, PS pressure support, RR respiratory rate, Vte exhaled tidal volume, PBW predicted body weight, FiO2 fraction of inspired oxygen, SpO2 peripheral capillary oxygen saturation, EPAP expiratory positive airway pressure, ICU intensive care unit
Fig. 2
Fig. 2
Musical intervention with the L-type sequence [24]. This sequence begins with a downswing phase, achieved by reducing the musical rhythms and the number of instruments, the frequencies, and the volume, and a maximum relaxation phase with a slow-paced rhythm and reduced orchestras (bottom of the L). bpm beats per minute
Fig. 3
Fig. 3
Hierarchical test procedure used for the primary endpoint analysis

References

    1. Demoule A, Girou E, Richard JC, Taille S, Brochard L. Increased use of noninvasive ventilation in French intensive care units. Intensive Care Med. 2006;32:1747–55. doi: 10.1007/s00134-006-0229-z.
    1. Brochard L, Mancebo J, Wysocki M, Lofaso F, Conti G, Rauss A, et al. Noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 1995;333:817–22. doi: 10.1056/NEJM199509283331301.
    1. L’Her E, Duquesne F, Girou E, de Rosiere XD, Le Conte P, Renault S, et al. Noninvasive continuous positive airway pressure in elderly cardiogenic pulmonary edema patients. Intensive Care Med. 2004;30:882–8. doi: 10.1007/s00134-004-2183-y.
    1. Park M, Sangean MC, Volpe MS, Feltrim MIZ, Nozawa E, Leite PF, et al. Randomized, prospective trial of oxygen, continuous positive airway pressure, and bilevel positive airway pressure by face mask in acute cardiogenic pulmonary edema. Crit Care Med. 2004;32:2407–15. doi: 10.1097/01.CCM.0000147770.20400.10.
    1. Ram FSF, Picot J, Lightowler J, Wedzicha JA. Non-invasive positive pressure ventilation for treatment of respiratory failure due to exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst. Rev. 2004;CD004104
    1. Girou E, Brun-Buisson C, Taillé S, Lemaire F, Brochard L. Secular trends in nosocomial infections and mortality associated with noninvasive ventilation in patients with exacerbation of COPD and pulmonary edema. JAMA. 2003;290:2985–91. doi: 10.1001/jama.290.22.2985.
    1. Antonelli M, Conti G, Moro ML, Esquinas A, Gonzalez-Diaz G, Confalonieri M, et al. Predictors of failure of noninvasive positive pressure ventilation in patients with acute hypoxemic respiratory failure: a multi-center study. Intensive Care Med. 2001;27:1718–28. doi: 10.1007/s00134-001-1114-4.
    1. Delclaux C, L’Her E, Alberti C, Mancebo J, Abroug F, Conti G, et al. Treatment of acute hypoxemic nonhypercapnic respiratory insufficiency with continuous positive airway pressure delivered by a face mask: a randomized controlled trial. JAMA. 2000;284:2352–60. doi: 10.1001/jama.284.18.2352.
    1. Carlucci A, Richard JC, Wysocki M, Lepage E, Brochard L. Noninvasive versus conventional mechanical ventilation. An epidemiologic survey. Am J Respir Crit Care Med. 2001;163:874–80. doi: 10.1164/ajrccm.163.4.2006027.
    1. Clouzeau B, Bui HN, Guilhon E, Grenouillet-Delacre M, Leger MS, Saghi T, et al. Fiberoptic bronchoscopy under noninvasive ventilation and propofol target-controlled infusion in hypoxemic patients. Intensive Care Med. 2011;37:1969–75. doi: 10.1007/s00134-011-2375-1.
    1. Constantin JM, Schneider E, Cayot-Constantin S, Guerin R, Bannier F, Futier E, et al. Remifentanil-based sedation to treat noninvasive ventilation failure: a preliminary study. Intensive Care Med. 2007;33:82–7. doi: 10.1007/s00134-006-0447-4.
    1. Akada S, Takeda S, Yoshida Y, Nakazato K, Mori M, Hongo T, et al. The efficacy of dexmedetomidine in patients with noninvasive ventilation: a preliminary study. Anesth Analg. 2008;107:167–70. doi: 10.1213/ane.0b013e3181732dc2.
    1. Devlin JW, Al-Qadheeb NS, Chi A, Roberts RJ, Qawi I, Garpestad E, et al. Efficacy and safety of early dexmedetomidine during noninvasive ventilation for patients with acute respiratory failure: a randomized, double-blind, placebo-controlled pilot study. Chest. 2014;145:1204–12. doi: 10.1378/chest.13-1448.
    1. Constantin JM, Perbet S, Futier E, Cayot-Constantin S, Gignac V, Bannier F, et al. Impact of sophrology on non-invasive ventilation tolerance in patients with acute respiratory failure. Ann Fr Anesth Reanim. 2009;28:215–21. doi: 10.1016/j.annfar.2008.12.028.
    1. Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. The Lancet [Internet]. 2015 [cited 2015 Aug 21]; . Accessed 21 Aug 2015.
    1. Dijkstra BM, Gamel C, van der Bijl JJ, Bots ML, Kesecioglu J. The effects of music on physiological responses and sedation scores in sedated, mechanically ventilated patients. J Clin Nurs. 2010;19:1030–9. doi: 10.1111/j.1365-2702.2009.02968.x.
    1. Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, et al. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013;309:2335–44. doi: 10.1001/jama.2013.5670.
    1. Han L, Li JP, Sit JW, Chung L, Jiao ZY, Ma WG. Effects of music intervention on physiological stress response and anxiety level of mechanically ventilated patients in China: a randomised controlled trial. J Clin Nurs. 2010;19:978–87. doi: 10.1111/j.1365-2702.2009.02845.x.
    1. Jaber S, Bahloul H, Guetin S, Chanques G, Sebbane M, Eledjam JJ. Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients. Ann Fr Anesth Reanim. 2007;26:30–8. doi: 10.1016/j.annfar.2006.09.002.
    1. Bradt J, Dileo C. Music interventions for mechanically ventilated patients. In: The Cochrane Collaboration, editor. Cochrane Database Syst. Rev. [Internet. Chichester: John Wiley & Sons, Ltd; 2014. [cited 2015 Aug 21]. .
    1. Kuchinke W, Ohmann C, Yang Q, Salas N, Lauritsen J, Gueyffier F, et al. Heterogeneity prevails: the state of clinical trial data management in Europe — results of a survey of ECRIN centres. Trials. 2010;11:79. doi: 10.1186/1745-6215-11-79.
    1. Hansson L, Hedner T, Dahlof B. Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point. Blood Press. 1992;1:113–9. doi: 10.3109/08037059209077502.
    1. Antonelli M, Conti G, Rocco M, Bufi M, De Blasi RA, Vivino G, et al. A comparison of noninvasive positive-pressure ventilation and conventional mechanical ventilation in patients with acute respiratory failure. N Engl J Med. 1998;339:429–35. doi: 10.1056/NEJM199808133390703.
    1. Guetin SGP, Blayac JP, Eledjam JJ. Une nouvelle technique contrôlée de musicothérapie dans la prise en charge des douleurs viscérales aiguës et chroniques. Doul Analg. 2005;8(1):19–25. doi: 10.1007/BF03014561.
    1. Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, et al. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012;28:329–37. doi: 10.1097/AJP.0b013e31822be973.
    1. Metnitz PG, Moreno RP, Almeida E, Jordan B, Bauer P, Campos RA, et al. SAPS 3 — From evaluation of the patient to evaluation of the intensive care unit. Part 1: Objectives, methods and cohort description. Intensive Care Med. 2005;31:1336–44. doi: 10.1007/s00134-005-2762-6.
    1. Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996;22:707–10. doi: 10.1007/BF01709751.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83. doi: 10.1097/00005650-199206000-00002.
    1. Chanques G, Jaber S, Barbotte E, Verdier R, Henriette K, Lefrant JY, et al. Validation of the French translated Richmond vigilance-agitation scale. Ann Fr Anesth Reanim. 2006;25:696–701. doi: 10.1016/j.annfar.2006.02.017.
    1. Weiss DS, Marmar CR. The Impact of Event Scale - Revised. In: Wilson J, Keane TM, editors. Assessing psychological trauma and PTSD. New York: Guilford; 1996. pp. 399–411.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309. doi: 10.7326/0003-4819-148-4-200802190-00008.
    1. Demidenko. Mixed models: theory and applications. New York: Wiley; 2012.
    1. Sterne JAC, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009;338:b2393. doi: 10.1136/bmj.b2393.
    1. Tzelepis F, Sanson-Fisher R, Zucca A, Fradgley E. Measuring the quality of patient-centered care: why patient-reported measures are critical to reliable assessment. Patient Prefer Adherence. 2015;9:831. doi: 10.2147/PPA.S81975.
    1. Richard J-C, Carlucci A, Breton L, Langlais N, Jaber S, Maggiore S, et al. Bench testing of pressure support ventilation with three different generations of ventilators. Intensive Care Med. 2002;28:1049–57. doi: 10.1007/s00134-002-1311-9.
    1. Carteaux G, Lyazidi A, Cordoba-Izquierdo A, Vignaux L, Jolliet P, Thille AW, et al. Patient-ventilator asynchrony during noninvasive ventilation: a bench and clinical study.Chest. 2012;142(2):367-376
    1. Tassaux D, Strasser S, Fonseca S, Dalmas E, Jolliet P. Comparative bench study of triggering, pressurization, and cycling between the home ventilator VPAP II and three ICU ventilators. Intensive Care Med. 2002;28:1254–61. doi: 10.1007/s00134-002-1421-4.
    1. Lellouche F, L’Her E, Abroug F, Deye N, Rodriguez PO, Rabbat A, et al. Impact of the humidification device on intubation rate during noninvasive ventilation with ICU ventilators: results of a multicenter randomized controlled trial. Intensive Care Med. doi:10.1007/s00134-013-3145-Z. 2013;1–9. LA – English
    1. Navalesi P, Fanfulla F, Frigerio P, Gregoretti C, Nava S. Physiologic evaluation of noninvasive mechanical ventilation delivered with three types of masks in patients with chronic hypercapnic respiratory failure. Crit Care Med. 2000;28:1785–90. doi: 10.1097/00003246-200006000-00015.
    1. Schettino GP, Tucci MR, Sousa R, Valente Barbas CS, Passos Amato MB, Carvalho CR. Mask mechanics and leak dynamics during noninvasive pressure support ventilation: a bench study. Intensive Care Med. 2001;27:1887–91. doi: 10.1007/s00134-001-1146-9.
    1. Bradt J, Dileo C, Grocke D, Magill L. Music interventions for improving psychological and physical outcomes in cancer patients. Cochrane Database Syst Rev. 2011;CD006911.
    1. Ottaviani S, Bernard JL, Bardin T, Richette P. Effect of music on anxiety and pain during joint lavage for knee osteoarthritis. Clin Rheumatol. 2011;31:531–4. doi: 10.1007/s10067-011-1925-9.
    1. Bechtold ML, Puli SR, Othman MO, Bartalos CR, Marshall JB, Roy PK. Effect of music on patients undergoing colonoscopy: a meta-analysis of randomized controlled trials. Dig Sci. 2009;54:19–24. doi: 10.1007/s10620-008-0312-0.
    1. Demoule A, Chevret S, Carlucci A, Kouatchet A, Jaber S, Meziani F, et al. Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries. Intensive Care Med. 2016;42:82–92. doi: 10.1007/s00134-015-4087-4.
    1. Azoulay E, Kouatchet A, Jaber S, Lambert J, Meziani F, Schmidt M, et al. Noninvasive mechanical ventilation in patients having declined tracheal intubation. Intensive Care Med 2013;39:292–301.
    1. Novaes MA, Knobel E, Bork AM, Pavão OF, Nogueira-Martins LA, Ferraz MB. Stressors in ICU: perception of the patient, relatives and health care team. Intensive Care Med. 1999;25:1421–6. doi: 10.1007/s001340051091.

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