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

NCT07704710 | Enrolling By Invitation

• 1 other identifier: 1616161616
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pressure Ulcer (PU)

Keywords

Pulse Oximetry; Intensive Care Units; Medical Device-Related Pressure Injury; Pulse Oximeter Probe; Pressure Injury Prevention

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

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.

Intervention Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Emine Arici Parlak: lead

Study Sites (1)

Univerisy of HelathSciences Turkiye Gulhane Faculty of Nursing

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 25, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)