Aerosol Therapy in Intensive Care Units

Critical Care Clinical Trial

— ATICU  

Official title:

Aerosol Therapy in Intensive Care Units: a Prospective Observation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597334
• Other study ID #: PekingUPH-lvshan
• Status: Completed
• Start date: July 9, 2018
• Est. completion date: August 10, 2018

Study information

• Verified date: December 2018
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1095
• Est. completion date: August 10, 2018
• Est. primary completion date: August 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients present in intensive care unit during the study period

Exclusion Criteria:

• patients refuse to participate in this study

Related Conditions & MeSH terms

• Critical Care
• Respiration, Artificial

Intervention

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

Locations

Country	Name	City	State
China	Shan Lyu	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
lvshan

Country where clinical trial is conducted

China, 

References & Publications (11)

Ari A, Areabi H, Fink JB. Evaluation of aerosol generator devices at 3 locations in humidified and non-humidified circuits during adult mechanical ventilation. Respir Care. 2010 Jul;55(7):837-44. — View Citation

Ari A, Atalay OT, Harwood R, Sheard MM, Aljamhan EA, Fink JB. Influence of nebulizer type, position, and bias flow on aerosol drug delivery in simulated pediatric and adult lung models during mechanical ventilation. Respir Care. 2010 Jul;55(7):845-51. — View Citation

Ari A, Harwood RJ, Sheard MM, Fink JB. Pressurized Metered-Dose Inhalers Versus Nebulizers in the Treatment of Mechanically Ventilated Subjects With Artificial Airways: An In Vitro Study. Respir Care. 2015 Nov;60(11):1570-4. doi: 10.4187/respcare.04125. Epub 2015 Jul 7. — View Citation

Ari A. Aerosol Therapy in Pulmonary Critical Care. Respir Care. 2015 Jun;60(6):858-74; discussion 874-9. doi: 10.4187/respcare.03790. Review. — View Citation

Dhanani J, Fraser JF, Chan HK, Rello J, Cohen J, Roberts JA. Fundamentals of aerosol therapy in critical care. Crit Care. 2016 Oct 7;20(1):269. Review. — View Citation

Dugernier J, Hesse M, Vanbever R, Depoortere V, Roeseler J, Michotte JB, Laterre PF, Jamar F, Reychler G. SPECT-CT Comparison of Lung Deposition using a System combining a Vibrating-mesh Nebulizer with a Valved Holding Chamber and a Conventional Jet Nebulizer: a Randomized Cross-over Study. Pharm Res. 2017 Feb;34(2):290-300. doi: 10.1007/s11095-016-2061-7. Epub 2016 Nov 7. — View Citation

Dugernier J, Reychler G, Wittebole X, Roeseler J, Depoortere V, Sottiaux T, Michotte JB, Vanbever R, Dugernier T, Goffette P, Docquier MA, Raftopoulos C, Hantson P, Jamar F, Laterre PF. Aerosol delivery with two ventilation modes during mechanical ventilation: a randomized study. Ann Intensive Care. 2016 Dec;6(1):73. doi: 10.1186/s13613-016-0169-x. Epub 2016 Jul 22. — View Citation

Dugernier J, Wittebole X, Roeseler J, Michotte JB, Sottiaux T, Dugernier T, Laterre PF, Reychler G. Influence of inspiratory flow pattern and nebulizer position on aerosol delivery with a vibrating-mesh nebulizer during invasive mechanical ventilation: an in vitro analysis. J Aerosol Med Pulm Drug Deliv. 2015 Jun;28(3):229-36. doi: 10.1089/jamp.2014.1131. Epub 2014 Nov 13. — View Citation

Ehrmann S, Roche-Campo F, Bodet-Contentin L, Razazi K, Dugernier J, Trenado-Alvarez J, Donzeau A, Vermeulen F, Thévoz D, Papanikolaou M, Edelson A, Yoshido HL, Piquilloud L, Lakhal K, Lopes C, Vicent C, Desachy A, Apiou-Sbirlea G, Isabey D, Brochard L; Reva Research Network; AT@ICU Study Group. Aerosol therapy in intensive and intermediate care units: prospective observation of 2808 critically ill patients. Intensive Care Med. 2016 Feb;42(2):192-201. doi: 10.1007/s00134-015-4114-5. Epub 2015 Nov 24. — View Citation

Galindo-Filho VC, Ramos ME, Rattes CS, Barbosa AK, Brandão DC, Brandão SC, Fink JB, de Andrade AD. Radioaerosol Pulmonary Deposition Using Mesh and Jet Nebulizers During Noninvasive Ventilation in Healthy Subjects. Respir Care. 2015 Sep;60(9):1238-46. doi: 10.4187/respcare.03667. Epub 2015 Jun 23. — View Citation

Lin HL, Fink JB, Zhou Y, Cheng YS. Influence of moisture accumulation in inline spacer on delivery of aerosol using metered-dose inhaler during mechanical ventilation. Respir Care. 2009 Oct;54(10):1336-41. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of aerosol therapy	how many aerosol therapy be administered in ICU patients	2 weeks
Secondary	drugs of aerosol therapy	the administration of atomized drugs , including type, dose, and frequency of use	2 weeks
Secondary	Side effects of aerosol therapy	any side effects during aerosol therapy,such as tachycardia ,hypertension,hypoxemia	2 weeeks
Secondary	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
Secondary	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
Secondary	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