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Enrolling by Invitation

NCT Number: NCT07704710

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univerisy of HelathSciences Turkiye Gulhane Faculty of Nursing

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse Oximeter Probe Repositioning Every 2 Hours

Device

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.

Pulse Oximeter Probe Repositioning Every 4 Hours

Device

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.

Primary outcomes

  1. Incidence of Medical Device-Related Pressure Injury at the Pulse Oximeter Probe Site

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emine Arici Parlak

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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