Aerosol Therapy in Intensive Care Units (ATICU)

December 2, 2018 updated by: lvshan

Aerosol Therapy in Intensive Care Units: a Prospective Observation Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1095

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 010
        • Shan Lyu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients present in intensive care unit during the study period

Description

Inclusion Criteria:

  • patients present in intensive care unit during the study period

Exclusion Criteria:

  • patients refuse to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
critical ill patients
critical ill patients who admit to ICU
Behavioral: aerosol therapy
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
drugs of aerosol therapy
Time Frame: 2 weeks
the administration of atomized drugs , including type, dose, and frequency of use
2 weeks
Side effects of aerosol therapy
Time Frame: 2 weeeks
any side effects during aerosol therapy,such as tachycardia ,hypertension,hypoxemia
2 weeeks
selection of the aerosol device
Time Frame: 2 weeeks
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
Time Frame: 2 weeeks
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
Time Frame: 2 weeeks
humidification condition can affect the delivery of atomized drugs.During aerosol therapy,how many practioner would switched off the heated humidifier
2 weeeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

lvshan

Investigators

  • Principal Investigator: Shan Lyu, Bacelor, Peking University People's hospital ,beijing ,China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2018

Primary Completion (Actual)

August 5, 2018

Study Completion (Actual)

August 10, 2018

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

July 16, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 2, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PekingUPH-lvshan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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