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临床试验/NCT02526862
NCT02526862已完成4 期

Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation. Randomized Clinical Trial

B. Braun Medical SA1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2012年2月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
152
试验地点
1
主要终点
Incidence of PU for each group (mean, standard deviation and quartiles)

研究概览

简要总结

This study aims to test direct application of the Non-Invasive Mechanical Ventilation -NIVM- mask or interface as the most efficient intervention to prevent Pressure Ulcers (PU), compared with other three usual preventive measures which consist in the use of three different medical devices.

详细描述

Non-Invasive Mechanical Ventilation (NIVM) has turned into a standard in the care of patients with acute respiratory failure. Defined as a support modality to the patient's spontaneous ventilation, it does not use invasive techniques to ventilate, working as an external device named interface or mask, avoiding so the complications associated to the invasive ventilation.

NIVM had been restricted to ICU and Pneumology services, but in the last years it has been extended to ER with good results and it is being also used in the pre-hospital attention and in the home care of chronic patient.

Often, the preferred interface is the oronasal, worst tolerated but associated to best treatment of the acute pathology. In most cases to avoid air leaks, its proper placement generates high pressure on the skin, being able to harm patient's tissues, so that this therapy as intervention for the acute patient has pressure ulcers -PU- as main iatrogenic effect - although 95% of the PU are considered as preventable-.

To diminish the pressure of the mask on the points of the face, nurses protect the most exposed zones with dressings of hydrogel-foam, polyurethane and/or hyperoxygenated fatty acids, trying to prevent PU.

Reviewed studies present a big variability in these practices as well as high dispersion of the results achieved.

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

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

入选标准

  • •Adults (≥18 years).
  • •Not tissue injury in face.
  • •Not structural deformation of the facial anatomy.

排除标准

  • •Rejects Informed Consent

研究组 & 干预措施

A-Mask or direct interface

No Intervention

Mask or direct interface

B-Autoadhesive polyurethane dressing

Active Comparator

Protection of the dermis with autoadhesive polyurethane dressing (Allevyn Thin®). The dressing will be standardized cut to avoid bias. The edges shape will be circular. They will be set in nasal bridge and cheekbones, avoiding frontal level. It will be checked every six hours, and if not properly fixed it will be applied again in the same way.

干预措施: Allevyn Thin® (Device)

C-Semi-permeable hydrogel-foam

Active Comparator

Protection of the dermis with semi-permeable hydrogel-foams adhesive dressing (Askina Transorbent Border®). The dressing will be standardized cut to avoid bias. The edges shape will be circular. They will be set in nasal bridge and cheekbones, avoiding frontal level. It will be checked every six hours, and if not properly fixed it will be applied again in the same way.

干预措施: Askina Transorbent Border® (Device)

D-Hyper hydrogenated fatty acids

Active Comparator

Protection of the dermis with hyper hydrogenated fatty acids (Linovera®) in the contact areas with the NIVM interface or mask. It will apply with its doser and gently massaged in chin, cheekbones, nasal and frontal bridge as indicated in the product. It will be checked every six hours for proper hydration and if needed it will be applied again in the same way.

干预措施: Linovera® (Device)

结局指标

主要结局

Incidence of PU for each group (mean, standard deviation and quartiles)

时间窗: First 24 hours after the withdrawal of the treatment

Compare the efficacy of the preventive treatments A, B, C and D - previously described-(meaning by efficacy the no occurrence of PU). For definition of PU investigators use the one of the "National Group for the Study and Advice in Pressure Ulcer and Chronic Wounds" (GNEAUPP)

次要结局

  • Efficiency of preventive measures for PU related to NIVM, by registering incidence and resources invested -time in hours and consumables in euros- (mean, standard deviation and quartiles for each group)(24 hours after the withdrawal of the treatment)
  • Incidence of total NIVM related PU, by observation registers.(24 hours after the withdrawal of the treatment)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

David Peña Otero

Nurse, Master of Science

Hospital General Universitario Gregorio Marañon

研究点 (1)

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