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"
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ankara, Turkije (Türkiye)
- Univerisy of HelathSciences Turkiye Gulhane Faculty of Nursing
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
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Actieve vergelijker: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Incidence of Medical Device-Related Pressure Injury at the Pulse Oximeter Probe Site
Tijdsspanne: Up to 4 hours after pulse oximeter probe placement
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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
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Medewerkers en onderzoekers
Sponsor
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
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Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1616161616
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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