"The Effect of Pulse Oximeter Probe Replacement Interval on Pressure Injury Development in Intensive Care Patients: A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Incidence of Medical Device-Related Pressure Injury at the Pulse Oximeter Probe Site
研究概览
简要总结
Patients admitted to intensive care units (ICUs) are at increased risk of medical device-related pressure injuries (MDRPIs) due to the prolonged use of monitoring devices. Pulse oximeter probes are routinely used for continuous monitoring of oxygen saturation and pulse rate and may contribute to pressure injury development when left in the same position for extended periods . Current international guidelines recommend regular assessment of the skin and repositioning of medical devices but do not specify an optimal repositioning interval. This randomized controlled trial aims to evaluate the effect of different pulse oximeter probe replacement intervals on the development of pressure injuries in adult ICU patients. The findings are expected to provide evidence to guide clinical practice and improve the prevention of medical device-related pressure injuries.
详细描述
Pulse oximetry is a non-invasive monitoring method that continuously measures arterial oxygen saturation (SpO₂) and pulse rate using optical sensors placed on peripheral tissues. It is widely used in intensive care units (ICUs), operating rooms, and other critical care settings for continuous patient monitoring . Although essential for patient care, prolonged application of pulse oximeter probes to the same anatomical site may increase the risk of medical device-related pressure injuries (MDRPIs), particularly in critically ill patients with impaired tissue perfusion, immobility, and fragile skin.
Medical device-related pressure injuries represent a substantial proportion of hospital-acquired pressure injuries and are associated with increased morbidity, prolonged hospitalization, and healthcare costs. International clinical practice guidelines recommend frequent skin assessment, regular repositioning of medical devices, prompt removal of unnecessary devices, and interventions to reduce pressure. However, these guidelines do not define an evidence-based interval for repositioning pulse oximeter probes, and current clinical practice varies considerably among healthcare institutions.
Several case reports have described tissue injury associated with prolonged pulse oximeter sensor application, including skin erosion and tissue necrosis at the finger, toe, ear, and forehead. Nevertheless, high-quality randomized controlled trials evaluating the optimal pulse oximeter probe replacement interval are lacking.
The primary objective of this randomized controlled trial is to determine whether different pulse oximeter probe replacement intervals influence the incidence of pressure injuries in adult ICU patients. The findings are expected to provide evidence for establishing standardized clinical protocols for pulse oximeter probe repositioning and contribute to the prevention of medical device-related pressure injuries in critically ill adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older
- •Written informed consent provided by the patient's legally authorized representative
- •Patients monitored with a pulse oximeter in the intensive care unit (ICU)
- •Glasgow Coma Scale (GCS) score of 8 or less
- •Expected or actual ICU stay of more than 72 hours
排除标准
- •Patients with severe peripheral edema
- •Patients with dermatological conditions that impair skin integrity
研究组 & 干预措施
Intervention Group
Patients will have a pulse oximeter probe placed on the right index finger. The probe site will remain unchanged for 2 hours. At the end of the 2-hour period, the probe will be removed, and the skin will be assessed for pressure injury using the Skin Assessment Form.
干预措施: Pulse Oximeter Probe Repositioning Every 2 Hours (Device)
Control Group
Patients will receive routine intensive care. The pulse oximeter probe will remain in the same position for 4 hours, consistent with standard ICU practice. At the end of the 4-hour period, the probe will be removed, and the skin will be assessed for pressure injury using the Skin Assessment Form.
干预措施: Pulse Oximeter Probe Repositioning Every 4 Hours (Device)
结局指标
主要结局
Incidence of Medical Device-Related Pressure Injury at the Pulse Oximeter Probe Site
时间窗: Up to 4 hours after pulse oximeter probe placement
The primary outcome is the incidence of medical device-related pressure injury (MDRPI) associated with pulse oximeter probe application in adult intensive care unit patients. Skin assessments will be performed using the Skin Assessment Form developed by the investigators based on the literature and the European Pressure Ulcer Advisory Panel (EPUAP) guidelines. The assessment includes: Presence or absence of medical device-related pressure injury Non-blanchable erythema Skin moisture Skin integrity Presence and severity of edema Tissue firmness Palpation findings Local skin temperature changes Pressure injury stage (Stage 1, Stage 2, Stage 3, Stage 4, Deep Tissue Injury, or Unstageable) The incidence of pressure injury will be compared between patients whose pulse oximeter probe is repositioned every 2 hours and those whose probe is repositioned every 4 hours.
次要结局
未报告次要终点
研究者
Emine Arici Parlak
Assistant Professor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi