A randomised controlled phase II trial to examine the feasibility of using hyper-oxygenated fatty acids (HOFA) to prevent facial pressure injuries from medical devices among adults admitted to intensive care-A research protocol.

Autor: Hunt L; Critical Care Research in Collaboration and Evidence Translation, Liverpool, NSW, Australia.; School of Nursing and Midwifery, Western Sydney University, Sydney, NSW, Australia., Ingleman J; School of Nursing, Midwifery and Social Work, Queensland University, Brisbane, QLD, Australia., Brennen K; Critical Care Research in Collaboration and Evidence Translation, Liverpool, NSW, Australia.; Department of Intensive Care, Bankstown-Lidcombe Hospital, Bankstown, NSW, Australia., Armstrong K; Department of Intensive Care, Bankstown-Lidcombe Hospital, Bankstown, NSW, Australia., Hazell M; Critical Care Research in Collaboration and Evidence Translation, Liverpool, NSW, Australia.; Department of Intensive Care, Liverpool Hospital, Liverpool, NSW, Australia., Keith N; Critical Care Research in Collaboration and Evidence Translation, Liverpool, NSW, Australia.; Department of Intensive Care, Liverpool Hospital, Liverpool, NSW, Australia.; School of Nursing, University of Wollongong, Wollongong, NSW, Australia., Bickford B; Department of Intensive Care, Liverpool Hospital, Liverpool, NSW, Australia., Sanchez D; Critical Care Research in Collaboration and Evidence Translation, Liverpool, NSW, Australia.; Department of Intensive Care, Campbelltown-Camden Hospital, Campbelltown, NSW, Australia., Khalil S; Department of Intensive Care, Campbelltown-Camden Hospital, Campbelltown, NSW, Australia., Geering S; South Western Sydney Nursing and Midwifery Research Alliance, Ingham Institute of Applied Medical Research, Liverpool Hospital, Liverpool, NSW, Australia.; Department of Intensive Care, Fairfield Hospital, Prairiewood, NSW, Australia., Sigdel SA; South Western Sydney Nursing and Midwifery Research Alliance, Ingham Institute of Applied Medical Research, Liverpool Hospital, Liverpool, NSW, Australia., Skaria S; Department of Intensive Care, Fairfield Hospital, Prairiewood, NSW, Australia., Prabhakaran S; Department of Intensive Care, Fairfield Hospital, Prairiewood, NSW, Australia., Lynch J; Critical Care Research in Collaboration and Evidence Translation, Liverpool, NSW, Australia.; School of Nursing and Midwifery, Western Sydney University, Sydney, NSW, Australia., Alexandrou E; Critical Care Research in Collaboration and Evidence Translation, Liverpool, NSW, Australia.; Department of Intensive Care, Liverpool Hospital, Liverpool, NSW, Australia.; School of Nursing, University of Wollongong, Wollongong, NSW, Australia.; South Western Sydney Nursing and Midwifery Research Alliance, Ingham Institute of Applied Medical Research, Liverpool Hospital, Liverpool, NSW, Australia., Drury P; School of Nursing, University of Wollongong, Wollongong, NSW, Australia., Tran T; Bone and Osteoporosis, Garvan Institute of Medical Research, Darlinghurst, NSW, Australia.; School of Biomedical Engineering, University of Technology Sydney, Ultimo, NSW, Australia., Frost SA; Critical Care Research in Collaboration and Evidence Translation, Liverpool, NSW, Australia.; Department of Intensive Care, Liverpool Hospital, Liverpool, NSW, Australia.; School of Nursing, University of Wollongong, Wollongong, NSW, Australia.; South Western Sydney Nursing and Midwifery Research Alliance, Ingham Institute of Applied Medical Research, Liverpool Hospital, Liverpool, NSW, Australia.
Jazyk: angličtina
Zdroj: International wound journal [Int Wound J] 2024 Oct; Vol. 21 (10), pp. e70069.
DOI: 10.1111/iwj.70069
Abstrakt: One in three patients admitted to intensive care will sustain a pressure injury (PI) from a medical device. These injuries are painful and when on the face, head or neck they can result in permanent disfigurement. Preliminary evidence of the efficacy of hyper-oxygenated fatty acids (HOFAs) to prevent facial pressure injuries from medical devices is promising; however, the feasibility of incorporating HOFAs into current standard care to prevent PI from a medical device of the face, head and neck has not been extensively explored. It is intended that the findings from this phase II feasibility study will inform the design of a larger phase III trial, by addressing two primary aims: (1) to assess the feasibility of incorporating HOFAs into standard care to prevent device-related pressure ulcers of the skin associated with the face, head and neck assess the feasibility and (2) efficacy preliminary effectiveness of HOFA. This feasibility study is an investigator-initiated mixed method study incorporating a multi-centre randomised controlled trial of using HOFAs as an adjunct to standard pressure injury prevention and care, compared with standard care alone to prevent facial, head or neck from medical devices among adults admitted to intensive care. The primary outcome of interest is the incidence of facial, head or neck pressure injuries during the first 14 days in intensive care. Secondary outcomes include PI staging, medical device exposure and intensive care and hospital outcomes. The primary analysis will be undertaken using Cox's Proportional Hazards model, and due to the exploratory nature of this phase II trial, efficacy will be based on a one-sided p-value for superiority set at 0.10. Type I and Type II error rates are set at 20%; therefore, a total sample size of 196 study participants is planned. To explore the feasibility of incorporating HOFA into usual care and to design a larger phase III trial, we will aim to interview between 10 and 20 nurses across participating intensive care unit sites. Pressure injuries of the face, head or neck from medical devices, among adults admitted to intensive care, are considered preventable. This phase II study will investigate the feasibility and efficacy of HOFAs as an adjunct to standard care. Importantly, we aim to inform the development of a larger phase III trial.
(© 2024 The Author(s). International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.)
Databáze: MEDLINE
Externí odkaz: