Clinical trial NCT03597334: Aerosol Therapy in Intensive Care Units
Official title: Aerosol Therapy in Intensive Care Units: a Prospective Observation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiration, Artificial
Critical Care
Keywords: administration,inhalation
metered dose inhalers
nebulizers and vaporizers
bronchodilator agents
anti-bacterial agents
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 1095
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients present in intensive care unit during the study period

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients present in intensive care unit during the study period

Exclusion Criteria:

* patients refuse to participate in this study

Primary outcomes:
measure: Frequency of aerosol therapy
timeFrame: 2 weeks
Secondary outcomes:
measure: drugs of aerosol therapy
timeFrame: 2 weeks
measure: Side effects of aerosol therapy
timeFrame: 2 weeeks
measure: selection of the aerosol device
timeFrame: 2 weeeks
measure: aerosol device's installation position
timeFrame: 2 weeeks
measure: humidification condition during aerosol therapy
timeFrame: 2 weeeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Shan Lyu
state: Beijing
Study officials:
affiliation: Peking University People's hospital ,beijing ,China
name: Shan Lyu, Bacelor
role: PRINCIPAL_INVESTIGATOR
References:
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