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临床试验/NCT05549830
NCT05549830尚未招募不适用

The Effect of Different Positioning Before, During and After Surgery on Pressure Injury: a Randomized Controlled Study Protocol

Marmara University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
Surgical pressure injury development

研究概览

简要总结

Background: Patients undergoing surgery are at risk of developing pressure injuries since they remain in a fixed position on the operating table under anesthesia for a long time. In the management of surgical patients, the prevention of surgical pressure injuries is the best strategy, requiring effective risk assessment and timely implementation of preventive interventions.

Aim: To evaluate the effect of preoperative and postoperative patient repositioning other than intraoperative positions on the development of pressure injuries.

H1 Hypothesis: In the preoperative and postoperative periods, there is a significant difference in the development of pressure injuries between patients who have been repositioned using non-surgical positions compared to those that did not undergo this intervention.

Methods: This study has been designed as a prospective randomized controlled trial. Patients meeting the inclusion criteria of the trial will be allocated to the intervention and control groups using a random number generator. The participants to be assigned to the intervention group will be placed in different positions other than their surgical positions on the night before surgery and until the first 36 hours after the operation, while the control group will only receive routine care. The groups will be evaluated in terms of pressure injury development for at least 72 hours until the end of the postoperative sixth day or discharge from the hospital.

详细描述

INTRODUCTION

Surgical interventions constitute one of the many risk factors that cause the development of pressure injuries. Since patients are in an immobile and fixed position during surgery and under the effect of anesthetic agents, they cannot feel the pain caused by pressure and shear forces or change their positions.Therefore, all patients undergoing surgical interventions are at risk of developing pressure injuries.

Surgical pressure injuries are those that occur during surgery or within the first 72 hours or first six days after surgery, and they are considered to be important complications that can have undesirable consequences. The development of surgical pressure injuries not only increases postoperative recovery time and length of hospital stay but also results in additional treatment requirement and pain experience for the patient, have adverse physical, mental, and financial effects, poses a risk of infection, and leads to reduced quality of life and deformities. In addition, the perioperative development of these injuries is an important indicator of the quality of care in terms of both the patient and the healthcare center and a serious safety issue for the former.

Despite technological advances, surgical pressure injuries remain a clinical problem for patients undergoing surgery. According to national and international studies, the prevalence of these injuries ranges from 0.3% to 66%, accounting for 4% to 45% of all hospital-acquired pressure injuries and shows an increasing trend in recent years. Among the risky surgical interventions listed in the literature are cardiac, general (abdominal and hepatobiliary), orthopedic, neurosurgical, vascular, urological, and thoracic operations.

The best strategy to manage pressure injuries is prevention rather than treatment. In this regard, it is recommended to perform an effective risk assessment and implement timely preventive interventions. The primary step is risk assessment, including the evaluation of associated risk factors and a comprehensive examination of skin condition, which helps identify high-risk cases in which to implement preventive interventions. Although many risk factors have been reported to contribute to the development of pressure injuries in patients undergoing surgery, the most important evidence-based risk factors have been shown to be preoperative immobility time, operation time, intraoperative hypothermia and hypotension, and immobility on the first postoperative day (level of evidence: weak; strength of recommendation: strong). Recommendations for prevention include patient positioning in a way to reduce the risk of pressure injury development during surgery (level of evidence: weak; strength of recommendation: strong), use of pressure support surfaces on the operating table (level of evidence: strong; strength of recommendation: weak), and redistribution of pressure before and after surgery (level of evidence: weak; strength of recommendation: strong). It is recommended that patients should be placed in different positions before and after surgery to redistribute pressure. However, there are a limited number of studies in the literature investigating the effectiveness of this application, which is based on a weak level of evidence but a strong recommendation, and it is emphasized that there is a need for further studies focusing on post-anesthesia nursing care and standards in practice.

研究设计

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

盲法说明

Masking will not be used. Participants meeting the inclusion criteria will be assigned to one of the two groups by randomization.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being scheduled to undergo elective major abdominal surgery that is expected to take three or more hours,
  • Being aged 18 years or older,
  • Having no communication problems,
  • Being able to communicate in Turkish,
  • Being conscious and having intact orientation function, i.e., awareness of place, person, and time,
  • Providing written informed consent to participate in the study.

排除标准

  • Being planned to undergo emergency major abdominal surgery,
  • Having preoperative pressure injuries.
  • Exclusion Criteria to be Applied After the İnitiation of the Study:
  • Defined as developing a contraindicated condition during postoperative positioning,
  • Being discharged within the first 72 hours postoperatively.

结局指标

主要结局

Surgical pressure injury development

时间窗: From at least 72 hours after surgery until the sixth postoperative day or discharge from the hospital if earlier.

Surgical pressure injuries will be assessed in six categories: stage I, non-blanchable erythema; stage II, partial-thickness skin loss; stage III, full-thickness skin loss; stage IV, full-thickness tissue loss; unstageable, depth unknown; and suspected deep tissue injury, depth unknown, according to the international classification system included in the "Prevention and Treatment of Pressure Ulcers: Quick reference Guide, 2014" published by the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, and Pan Pacific Pressure Injury Alliance (NPUAP/EPUAP/PPPIA).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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