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临床试验/NCT03597334
NCT03597334已完成不适用

Aerosol Therapy in Intensive Care Units: a Prospective Observation Study

lvshan1 个研究点 分布在 1 个国家目标入组 1,095 人开始时间: 2018年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,095
试验地点
1
主要终点
Frequency of aerosol therapy

研究概览

简要总结

Unlike in the outpatient setting, delivery of aerosols to ICU patients may be considered complex, particularly in ventilated patients. Successful delivery of aerosolized medications to ICU patients depends upon the selection of the aerosol device and its installation position, the humidification condition, and the adjustment of the ventilator mode and parameters, etc. And there is currently little guidance or information on standards of practice in aerosol therapy.

Purpose:The aim of the present work was to assess the frequency, modalities of aerosol therapy in critically ill patients either breathing spontaneously or undergoing invasive or noninvasive ventilation.

Method:This prospective cross-sectional point prevalence study will be carried out over 14 days in several intensive care units. Centers are recruited on a voluntary basis.

During the study period, characteristics of each ICU patient will be prospectively recorded each day. If patients receive inhaled medication during the study period, extensive data such as the selection of the aerosol device and its installation position will be recorded.

Data will be entered into a database and analyses will be performed using SPSS soft ware. A p value lower than 0.05 is considered significant.

详细描述

Patients admitted to intensive care units (ICUs) are usually critically ill. Aerosol inhalation therapy is important for these patients. Aerosol inhalation therapy refers to a local administration method in which a drug is made into aerosol particles having a very small diameter and is inhaled by a patient and the drug directly acts on the airway. Unlike in the outpatient setting, delivery of aerosols to ICU patients may be considered complex, particularly in ventilated patients. Large particles generated by any aerosol device are trapped in the ventilator circuit and artificial airways. Moreover, the percentage of the emitted drug that is delivered past artificial airways as aerosol is lower with larger particle size. Successful delivery of aerosolized medications to ICU patients depends upon the selection of the aerosol device and its installation position, the humidification condition, and the adjustment of the ventilator mode and parameters, etc. Therefore, physicians and health-care professionals working in ICU must be adequately trained in the proper use of each aerosol device and other aerosol inhalation techniques. Otherwise, patients will receive a suboptimal dose that will not be beneficial. An international multi-center cross-sectional survey has shown that a considerable portion of aerosol inhalation therapy for patients with invasive and non-invasive ventilation need to be regulated. And there is currently little guidance or information on standards of practice in aerosol therapy. Therefore, it is necessary to carry out this study to investigate and evaluate the current clinical treatment of aerosol therapy, in order to carry out relevant education and training, and ultimately develop the standards of aerosol inhalation therapy practice in ICU.

Purpose The aim of the present work was to assess the frequency, modalities of aerosol therapy in critically ill patients either breathing spontaneously or undergoing invasive or noninvasive (NIV) ventilation.

Method This prospective cross-sectional point prevalence study will be carried out over 14 days in several intensive care units. Centers are recruited on a voluntary basis.

During the study period, characteristics of each ICU patient will be prospectively recorded each day. If patients receive inhaled medication during the study period, extensive data such as the selection of the aerosol device and its installation position will be recorded.

Data will be entered into a database and analyses will be performed using SPSS soft ware . The 95 % confidence interval (CI95) of proportions are calculated for the main variables of aerosol therapy. A p value lower than 0.05 is considered significant.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • patients present in intensive care unit during the study period

排除标准

  • patients refuse to participate in this study

结局指标

主要结局

Frequency of aerosol therapy

时间窗: 2 weeks

how many aerosol therapy be administered in ICU patients

次要结局

  • aerosol device's installation position(2 weeeks)
  • humidification condition during aerosol therapy(2 weeeks)
  • drugs of aerosol therapy(2 weeks)
  • Side effects of aerosol therapy(2 weeeks)
  • selection of the aerosol device(2 weeeks)

研究者

发起方
lvshan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

lvshan

respiratory therapist

Peking University People's Hospital

研究点 (1)

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