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临床试验/NCT06974552
NCT06974552招募中不适用

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

Acibadem University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年5月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
72
试验地点
1
主要终点
Change in the pressure injury condition

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Experimental Group (Microbead-Filled Support Surface)

Experimental

Patients undergoing robotic surgery in the deep Trendelenburg position who received microbead-filled support surfaces applied to the shoulder areas.

干预措施: microbead-filled support surfaces (Procedure)

Control Group (gel support surfaces )

Other

Patients undergoing robotic surgery in the deep Trendelenburg position who received gel support surfaces applied to the shoulder areas.

干预措施: Jel support surfaces (Procedure)

结局指标

主要结局

Change in the pressure injury condition

时间窗: 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.

The presence or absence of pressure injuries in patients will be assessed. If a pressure injury is present, it will be staged accordingly. Pressure injury assessment will be conducted in accordance with the guidelines of the European Pressure Ulcer Advisory Panel (EPUAP) and the National Pressure Ulcer Advisory Panel (NPUAP)

Change in the pain level

时间窗: 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.

The patient's pain will be assessed using the Visual Analog Scale (VAS). VAS is a simple and widely used tool for measuring subjective experiences such as pain. It typically consists of a 10 cm horizontal line, with the left end representing 'no pain' (0) and the right end representing 'worst imaginable pain' (10). The participant is asked to mark the point on the line that best reflects the intensity of their pain.

次要结局

未报告次要终点

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ukke Karabacak

Principal investigator

Acibadem University

研究点 (1)

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