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临床试验/NCT06819800
NCT06819800已完成不适用

The Effect of Three Different Nasogastric Tube Fixation Materials on Pressure Injury in the Intensive Care Unit

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年12月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Glasgow Coma Scale

研究概览

简要总结

This randomized controlled experimental study aims to comparatively determine the effects of three different nasogastric tube fixation materials (elastic plaster, medical silk plaster, transparent waterproof plaster) on pressure injuries in adult patients hospitalized in ICU.

This study was carried out in the Intensive Care Units (ICU) of a university-affiliated training and research hospital in Istanbul, Turkey. 84 patients were divided into three groups of 28 patients each, and were fixed with different materials. Data were collected using the Patient Information Form, Patient Follow-up Form, Braden Pressure Wound Risk Assessment Scale, Glasgow Coma Scale, and Nasogastric Tube-Related Pressure Injuries Staging and Follow-up Form. The data were analyzed using the Statistical Package for Social Sciences (SPSS) v27 statistical analysis program. The frequency and severity of pressure injuries between groups were evaluated by statistical methods such as Chi-square analysis, analysis of variance and Bonferroni test.

详细描述

Purpose and Design Type of the Study The aim of this study with a randomized controlled experimental design was to examine the effects of three different nasogastric tube fixation materials on pressure injury in adult patients hospitalized in the Intensive Care Unit (ICU).

Research Hypothesis H0: Different nasogastric tube fixation materials have no significant effect in preventing pressure injuries.

H1: Different nasogastric tube fixation materials have a significant effect on preventing pressure injuries.

Variables of the Study Dependent Variables: Pressure injury development. Independent Variables: Three different nasogastric tube fixation materials and individual/disease characteristics of patients.

Place and Time of the Study This study was conducted between December 28, 2023 and June 2024 in the Intensive Care Units (ICU) of a university-affiliated training and research hospital in Istanbul.

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Between the ages of 18-65
  • •Duration of hospitalization in the ICU should be at least 24 hours
  • •Having no cognitive and affective problems
  • •Nasogastric (NG) tube insertion for the first time and tube placement for at least 72 hours
  • •Nasogastric tube maintenance at least once a day
  • •Glasgow Coma Scale (GCS) score of 9 and above
  • •Oxygen support is not provided with medical devices
  • •No skin problem that may prevent skin diagnostics
  • •No burns/trauma in the face and nose area/operation not to spend
  • •No history of pressure injury to the nose
  • •The absence of a diagnosis of Diabetes Mellitus (DM) was determined.

排除标准

  • •Under 18 or over 65 years of age
  • •Having a state of consciousness or affective problem(s)
  • •GCS score below 9
  • •The presence of facial problem(s) that may prevent nasogastric tube insertion.

研究组 & 干预措施

Elastic Flaster

Active Comparator

Elastic Flaster:

Elastic flaster is a hypoallergenic therapeutic product and is made of an elastic, non-woven fabric. It has a polyacrylate adhesive, which allows it to be easily fixed. Thanks to its porous structure, it allows air intake, recognition and moisture permeability. Elastic plasters, which easily adapt to the connections with their flexible structure body structures, adapt to the natural movements of the skin and increase the comfort of the patient. This feature may be especially preferred for patients who move a lot. Although elastic dressings are generally more affordable than other types of dressings, they may increase costs in the long term due to frequent replacement. In the Intensive Care Unit, elastic plasters are routinely used for nasogastric tube fixation.

干预措施: Elastic Flaster (Other)

Medical Silk Flaster

Experimental

Medical Silk Flasters:

Medical silk flaster is a medical material made of acetate silk with rubber-based fittings containing mineral oxide. It is used for fixation in surgical applications. It is effective in fixing materials such as catheters, cover cloths and wound dressings thanks to its strong adhesive properties. The material used in its content provides a clean appearance compatible with the skin and increases comfort. However, this type of flasters may cause skin irritation in some patients with prolonged use. The cost of silk flasters is moderate, and their high adhesive properties make them cost-effective in the long term as they require fewer changes.

干预措施: Medical Silk Flaster (Other)

Transparent Waterproof Flaster

Experimental

Transparent Waterproof Waterproof Flaster The transparent waterproof patch is a hypoallergenic product suitable for sensitive skin. It offers an ideal use for the storage of maintenance and repair areas. It is effectively used for fixing the number of medical supplies. The transparent structure allows for clearer observation of operations. These flasters perform well even in humid environments and reduce the risk of infection. It has a strong adhesive, long-lasting feature and does not cause any residue on the skin after use. It can be easily torn by hand both transversely and longitudinally, ensuring user practicality.

干预措施: Transparent Waterproof Flaster (Other)

结局指标

主要结局

Glasgow Coma Scale

时间窗: Baseline, 72 hours and average 15 days

Developed in Glasgow, Scotland in 1974, the GCS is a common scale used to assess the state of consciousness of comatose patients. It consists of three parameters: "eye openness", "verbal and motor response". The total score ranges from 3 to 15, with 3 points indicating deep coma and 15 points indicating full awareness and alertness.

Braden Pressure Ulcer Risk Assessment Scale

时间窗: Baseline, 72 hours and average 15 days

Developed in 1984 by Braden and used to assess pressure sore risk factors, this scale was improved by Braden and Bergstrom in 1987. The subscales of the scale include stimulus perception, activity, movement, moisture, nutrition and friction-tearing. The scores obtained from the sub-dimensions constitute the total scale score. The score range is 6-23, and the lower the score, the higher the risk of developing pressure sores. According to the scale score, risk levels are classified as "12 and below high risk", "13-14 medium risk", "15-16 low risk". A score of 15-18 is considered low risk in people aged 75 years and older.

次要结局

  • Nasogastric Tube Related Pressure Injuries Follow-up Questionnaire(on average 10-15 days after the wound is formed in the patient)
  • patient information questionnaire(Baseline)
  • patient nasal area monitoring questionnaire(Baseline, 72 hours and average 15 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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