The Effect of Pulse Oximeter Probe Replacement Interval on Pressure Injury Development in Intensive Care Patients

"The Effect of Pulse Oximeter Probe Replacement Interval on Pressure Injury Development in Intensive Care Patients: A Randomized Controlled Trial"

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pressure Ulcer (PU)
• Intervention / Treatment: Device: Pulse Oximeter Probe Repositioning Every 2 Hours; Device: Pulse Oximeter Probe Repositioning Every 4 Hours

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 432
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Univerisy of HelathSciences Turkiye Gulhane Faculty of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with severe peripheral edema
• Patients with dermatological conditions that impair skin integrity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Pulse Oximeter Probe Repositioning Every 2 Hours; The pulse oximeter probe will be placed on the patient's right index finger and repositioned every 2 hours. After 2 hours, the probe will be removed, the skin will be assessed for pressure injury using the Skin Assessment Form, and the probe will be repositioned according to the study protocol.
Active Comparator: 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.	Device: Pulse Oximeter Probe Repositioning Every 4 Hours; The pulse oximeter probe will remain in the same position for 4 hours in accordance with routine intensive care unit practice. After 4 hours, the probe will be removed, the skin will be assessed for pressure injury using the Skin Assessment Form, and routine care will continue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Medical Device-Related Pressure Injury at the Pulse Oximeter Probe Site	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.	Up to 4 hours after pulse oximeter probe placement

Collaborators and Investigators

• Sponsor: Emine Arici Parlak

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 25, 2027

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care Units; Pressure Injury Prevention; Pulse Oximetry; Medical Device-Related Pressure Injury; Pulse Oximeter Probe
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Pressure Ulcer
• Other Study ID Numbers: 1616161616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No