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临床试验/NCT01828151
NCT01828151已完成不适用

Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers in Patients With Acute Respiratory Failure

Ospedale S. Giovanni Bosco1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
170
试验地点
1
主要终点
Risk of skin pressure ulcers in patients treated with noninvasive ventilation for acute respiratory failure.

研究概览

简要总结

To assess risk of skin pressure lesions in patients treated with noninvasive mechanical ventilation.

详细描述

Noninvasive ventilation improves the outcome of patients with acute respiratory failure; however patient's discomfort may be responsible for up to a fifth of failures. Scant literature exists on NIV-related pressure ulcers and their determinants.

Aim of the study is to seek for determinants, if any, associated with the development of pressure ulcers related to noninvasive ventilation.

Study design: observational. Patients treated with NIV from December 2009 to December 2011 will be analyzed. Main end-points: to seek for variables associated to the development of NIV-related pressure ulcers in patients with acute respiratory failure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • severe dyspnea at rest
  • respiratory rate > 30 per minute
  • PaO2/FiO2 < 200 (despite oxygen with Venturi with a FiO2 og 0.5)
  • use of accessory respiratory muscles
  • pH < 7.35 > 7.10

排除标准

  • NSTEMI/Unstable angina
  • Hemodynamic instability
  • Need for immediate endotracheal intubation
  • Inability to protect the airways
  • Impaired sensorium
  • Pulmonary embolism
  • Gastrointestinal bleeding
  • Hematological malignancy or neoplasms with ECOG performance status > 2

结局指标

主要结局

Risk of skin pressure ulcers in patients treated with noninvasive ventilation for acute respiratory failure.

时间窗: Risk of pressure ulcers within 72 hours from noninvasive ventilation beginning.

Skin lesions were classified as follows: * reddening, * loss of skin integrity, * necrotic lesion.

次要结局

  • Incidence of skin pressure ulcers in patients treated with noninvasive ventilation.(Incidence of skin pressure ulcers. Patients will be followed during duration of high dependency unit stay for an average length of stay of 7 days.)

研究者

发起方
Ospedale S. Giovanni Bosco
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Ferrari

Dr

Ospedale S. Giovanni Bosco

研究点 (1)

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