Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

Olga L Cortés, Mauricio Herrera-Galindo, Juan Carlos Villar, Yudi A Rojas, María Del Pilar Paipa, Luzdary Salazar, Olga L Cortés, Mauricio Herrera-Galindo, Juan Carlos Villar, Yudi A Rojas, María Del Pilar Paipa, Luzdary Salazar

Abstract

Background: Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients' tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals.

Methods: A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients' level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study.

Conclusion: This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk.

Trial registration: PENFUP phase-2 was Registered in Clinicaltrials.gov ( NCT04604665 ) in October 2020.

Keywords: Bedsores; Clinical trial; Clusters; Critical care; Nursing; Pressure ulcers; Randomized.

Conflict of interest statement

The authors OLC, JCV, MH-G, YAR, LDS, MPP declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Consort flow diagram
Fig. 2
Fig. 2
SPIRIT timeline of the study. The complete timeline of the study is about 36 months

References

    1. Ministerio de salud y protección social . Prevención Ulceras por presión; Guía técnica “buenas prácticas para la seguridad del paciente en la atención en salud”. 2015. Capítulo 7: Marco teórico; pp. 29–31.
    1. MacLeod FE, Harrison MB, Graham ID. The process of developing best practice guidelines for nurses in Ontario: risk assessment and prevention of pressure ulcers. Ostomy Wound Manage. 2002;48(10):30–32.
    1. NPUAP . In: Prevention and treatment of pressure ulcers: quick reference guide. National Pressure Ulcer Advisory Panel (NPUAP), European pressure ulcer advisory panel (EPUAP), Pan Pacific pressure injury Alliance (PPPlA), editor. 2014.
    1. World Health Organization. World report on ageing and health: summary: World Health Organization; 2015.
    1. Lima Serrano M, González Méndez MI, Carrasco Cebollero FM, Lima Rodríguez JS. Risk factors for pressure ulcer development in Intensive Care Units: A systematic review. Med Intensiva. 2017;41(6):339–346. doi: 10.1016/j.medin.2016.09.003.
    1. Cortés OL, Salazar-Beltrán LD, Rojas Castañeda YA, Alvarado Muriel PA, Serna Restrepo A, Grinspun D. Use of hydrocolloid dressings in preventing pressure ulcers in High-risk Patients: a Retrospective Cohort. Invest Educ Enferm. 2018;36(1):1–12. doi: 10.17533/udea.iee.v36n1e11.
    1. Gillespie BM, Chaboyer WP, McInnes E, Kent B, Whitty JA, Thalib L. Repositioning for pressure ulcer prevention in adults. Cochrane Database Syst Rev. 2014;2014(4):CD009958. doi: 10.1002/14651858.CD009958.pub2.
    1. Källman U. Evaluation of Repositioning in Pressure Ulcer Prevention. 2015.
    1. Nijs N, Toppers A, Defloor T, Bernaerts K, Milisen K, Van Den Berghe G. Incidence and risk factors for pressure ulcers in the intensive care unit. J Clin Nurs. 2009;18(9):1258–1266. doi: 10.1111/j.1365-2702.2008.02554.x.
    1. Phillips L, Buttery J. Exploring pressure ulcer prevalence and preventative care. Nurs Times. 2009;105(16):34–36.
    1. VanGilder C, Amlung S, Harrison P, Meyer S. Results of the 2008-2009 international pressure ulcer prevalence survey and a 3-year, acute care, unit-specific analysis. Ostomy Wound Manage. 2009;55(11):39–45.
    1. Woodbury MG, Houghton PE. Prevalence of pressure ulcers in Canadian healthcare settings. Ostomy Wound Manage. 2004;50(10):22–39.
    1. Lynch S, Vickery P. Steps to reducing hospital-acquired pressure ulcers. Nursing. 2010;40(11):61–62. doi: 10.1097/01.NURSE.0000387754.83476.77.
    1. Coleman S, Gorecki C, Nelson EA, Closs SJ, Defloor T, Halfens R, Farrin A, Brown J, Schoonhoven L, Nixon J. Patient risk factors for pressure ulcer development: systematic review. Int J Nurs Stud. 2013;50(7):974–1003. doi: 10.1016/j.ijnurstu.2012.11.019.
    1. Lindgren M, Unosson M, Fredrikson M, Ek AC. Immobility--a major risk factor for development of pressure ulcers among adult hospitalized patients: a prospective study. Scand J Caring Sci. 2004;18(1):57–64. doi: 10.1046/j.0283-9318.2003.00250.x.
    1. Eldridge S, Kerry S. Designing interventions. In: A practical guide to cluster randomized trials in health services research. Centre for Primary Care and Public Health, Barts, and The London School of Medicine and Dentistry, Queen Mary University of London UK: John Wiley & Sons, Ltda; 2012. p. 44–57.
    1. PENFUP. Study phase l. Evaluación del impacto del uso de protectores de piel versus cuidado convencional con lubricación de piel en la prevención de úlceras por presión en pacientes de alto y muy alto riesgo que ingresan a todos los servicios de atención médico-quirúrgicos: ensayo clínico multicéntrico. lnforme Técnico Final de Programas y Proyectos del CTel. Colombia: Colciencias; 2014.
    1. Chaboyer W, Bucknall T, Webster J, McInnes E, Gillespie BM, Banks M, Whitty JA, Thalib L, Roberts S, Tallott M, Cullum N, Wallis M. The effect of a patient-centered care bundle intervention on pressure ulcer incidence (INTACT): a cluster randomized trial. Int J Nurs Stud. 2016;64:63–71. doi: 10.1016/j.ijnurstu.2016.09.015.
    1. Eldridge S, Kerry S. Sample size calculations. In: John Wiley & Sons, editors. A practical guide to cluster randomized trials in health services research. London: United Kingdom; 2012. p. 137–69
    1. Eldridge S, Kerry S. Intra-cluster correlation coefficient. In: John Wiley & Sons, editors. A practical guide to cluster randomized trials in health services research. London: United Kingdom; 2012. p. 172–91.
    1. National Pressure Ulcer Advisory Panel Pressure ulcer prevalence, cost, and risk assessment: consensus development conference statement. Decubitus. 1989;2(2):24–28.
    1. Grupo Nacional para el Estudio y Asesoramiento en Úlceras por Presión y Heridas Crónicas (GNEAUPP) Clasificación-estadiaje de las úlceras por presión. Doc.II. Logroño: GNEAUPP; 2003.
    1. Eldridge S, Kerry S. Analysis. In: In: John Wiley & Sons, editors. A practical guide to cluster randomized trials in health services research. London: United Kingdom; 2012. p. 99–131
    1. Brindle CT, Malhotra R, Oʼrourke S, Currie L, Chadwick D, Falls P, Adams C, Swenson J, Tuason D, Watson S, Creehan S. Turning and repositioning the critically ill patient with hemodynamic instability: a literature review and consensus recommendations. J Wound Ostomy Continence Nurs. 2013;40(3):254–267. doi: 10.1097/WON.0b013e318290448f.

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