Aerosol Therapy in Intensive Care Units

Study Overview
=================
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.

Official Title
-----------------
Aerosol Therapy in Intensive Care Units: a Prospective Observation Study

Conditions
-----------------
Respiration, Artificial, Critical Care

Intervention / Treatment
-----------------
* Behavioral: aerosol therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients present in intensive care unit during the study period Exclusion Criteria: patients refuse to participate in this study
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| critical ill patients<br>critical ill patients who admit to ICU | Behavioral: aerosol therapy<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of aerosol therapy | how many aerosol therapy be administered in ICU patients | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drugs of aerosol therapy | the administration of atomized drugs , including type, dose, and frequency of use | 2 weeks | 
| Side effects of aerosol therapy | any side effects during aerosol therapy,such as tachycardia ,hypertension,hypoxemia | 2 weeeks | 
| selection of the aerosol device | there are differernt types of aerosol devices which have their own characteristics.what kind of aerosol device they choose,for example pneumatic nebulizer or ultra-sonic nebulizer or vibrating mesh nebulizer or hand held devices.which is the most popullar aerosol device. | 2 weeeks | 
| aerosol device's installation position | For mechanical ventilated patients,position of the aerosol device in the ventilatory circuit can affect the delivery of atomized drugs.which position do practioners would choose: distal from the Y piece or inspiratory limb just before the Y piece. | 2 weeeks | 
| humidification condition during aerosol therapy | humidification condition can affect the delivery of atomized drugs.During aerosol therapy,how many practioner would switched off the heated humidifier | 2 weeeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
administration,inhalation, metered dose inhalers, nebulizers and vaporizers, bronchodilator agents, anti-bacterial agents