The Effect of Different Support Surface Applications

Официальное название

The Effect of Different Support Surface Applications on Pressure Injury and Pain in Patients Undergoing Robotic Surgery

Обзор

This study was designed as a randomized controlled experimental study to compare the effects of two support surfaces-gel pads (used in routine practice) and microbead-filled pads-placed under the shoulders in the steep Trendelenburg position during robotic surgery, on the development of pressure injuries and pain.

Подробное описание

Safe and procedure-specific patient positioning is a critical component of successful surgical outcomes. In robotic surgeries, particularly those involving the lower pelvic region, the steep Trendelenburg position is frequently used to optimize surgical exposure. However, as the angle of the Trendelenburg position increases and the patient remains in this posture for a prolonged period, the risk of adverse events such as nerve injuries, pressure injuries, and deep tissue ischemia also increases.

Unlike traditional surgeries where repositioning the patient may be possible during the procedure, robotic surgeries do not allow for intraoperative repositioning due to the fixed docking of robotic arms. Consequently, safe and effective positioning strategies are essential to prevent patient movement and minimize the risk of skin and soft tissue damage.

The current systems used for managing patients in the steep Trendelenburg position are suboptimal. There is limited evidence in the literature regarding the incidence and prevention of pressure injuries associated with this specific position during robotic surgery. Prolonged immobility in this posture increases friction and pressure at contact surfaces, which can lead to pressure-related injuries.

The use of appropriate support surfaces is therefore vital to reduce the risk of such injuries. This study aims to address this gap by evaluating and comparing different support surfaces placed under the shoulders during robotic surgery in the steep Trendelenburg position, with a focus on their effects on pressure injury development and postoperative pain.

Hypotheses of the study H1: The use of microbead-filled support surfaces under the shoulders is superior to gel support surfaces in preventing pressure injuries and pain.

H2: The use of gel support surfaces under the shoulders is superior to microbead-filled support surfaces in preventing pressure injuries and pain.

Вмешательства

• Процедура microbead-filled support surfaces
  Patients will undergo a preoperative pressure injury risk assessment. After the induction of general anesthesia, a multilayer silicone wound dressing will be applied to the shoulder area. The shoulder will then be supported using microbead-filled support surfaces. This support surface will remain in place throughout the duration of the surgery.
• Процедура Jel support surfaces
  Patients will undergo a preoperative pressure injury risk assessment. After the induction of general anesthesia, a multilayer silicone wound dressing will be applied to the shoulder area. The shoulder will then be supported using jel support surfaces. This support surface will remain in place throughout the duration of the surgery.

Первичные конечные точки

• Change in the pressure injury condition [Срок оценки: At the time of admission to the operating room, immediately after surgery, one hour after surgery, 12 hour after surgery, 24 hour after surgery. The change in this time intervals will be assessed.]
• Change in the pain level [Срок оценки: Pain will be assessed every 15 minutes during the first two hours after surgery, and then every 30 minutes for the following one hour.The change in this time intervals will be assessed.]

Критерии участия

Критерии включения

• Patients scheduled to undergo robotic surgery in the lower pelvic region in the steep Trendelenburg position
• Patients aged 18 years and older

Критерии исключения

• Patients with existing pressure injuries
• Patients with communication barriers
• Patients with skin anomalies that interfere with skin assessment
• Patients requiring conversion to open surgery during the procedure
• Patients whose position is changed during surgery

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Acibadem University — Istanbul

Публикации

• Safe Practices When Positioning Patients in the Trendelenburg Position. AORN J. 2024 May;119(5):P9. doi: 10.1002/aorn.14134. No abstract available. PMID 38661435
• Celik B, Karayurt O, Ogce F. The Effect of Selected Risk Factors on Perioperative Pressure Injury Development. AORN J. 2019 Jul;110(1):29-38. doi: 10.1002/aorn.12725. PMID 31246295
• Engels D, Austin M, McNichol L, Fencl J, Gupta S, Kazi H. Pressure Ulcers: Factors Contributing to Their Development in the OR. AORN J. 2016 Mar;103(3):271-81. doi: 10.1016/j.aorn.2016.01.008. PMID 26924365
• Chen Y, Wang W, Qian Q, Wu B. Comparison of four risk assessment scales in predicting the risk of intraoperative acquired pressure injury in adult surgical patients: a prospective study. J Int Med Res. 2023 Oct;51(10):3000605231207530. doi: 10.1177/03000605231207530. PMID 37898108

Идентификаторы

NCT: NCT06974552 · ATADEK-2025/06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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