Respiration, ArtificialATICUNCT03597334
Aerosol Therapy in Intensive Care Units
An observational study of Respiration, Artificial and Critical Care, run by lvshan at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiration, Artificial, Critical Care
- What is being tested?
- aerosol therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,095 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2018to 10 Aug 2018
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients present in intensive care unit during the study period
Who may be able to join
- patients present in intensive care unit during the study period
Who cannot join
- patients refuse to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Respiration, Artificial, Critical Care
- Being tested
- aerosol therapy
- Keywords
- administration,inhalation, metered dose inhalers, nebulizers and vaporizers, bronchodilator agents, anti-bacterial agents
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerosol therapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| critical ill patients | critical ill patients who admit to ICU Receives: Behavioral: aerosol therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of aerosol therapy
how many aerosol therapy be administered in ICU patients
Measured: 2 weeks
Secondary outcomes (5)
drugs of aerosol therapy
the administration of atomized drugs , including type, dose, and frequency of use
Measured: 2 weeks
Side effects of aerosol therapy
any side effects during aerosol therapy,such as tachycardia ,hypertension,hypoxemia
Measured: 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.
Measured: 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.
Measured: 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
Measured: 2 weeeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start9 Jul 2018
- Primary completion5 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,095 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- lvshan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, lvshan, Peking University People's Hospital
- Investigators
- Shan Lyu, Bacelor, Principal investigator, Peking University People's hospital ,beijing ,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597334
- Sponsor's protocol ID
- PekingUPH-lvshan
- Acronym
- ATICU
- Status last verified
- Dec 2018
- First submitted
- 19 Jun 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ari A. Aerosol Therapy in Pulmonary Critical Care. Respir Care. 2015 Jun;60(6):858-74; discussion 874-9. doi: 10.4187/respcare.03790.
PubMed 26070580Dhanani 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. doi: 10.1186/s13054-016-1448-5.
PubMed 27716346Ari 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.
PubMed 26152470Dugernier 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.
PubMed 27822851Galindo-Filho VC, Ramos ME, Rattes CS, Barbosa AK, Brandao DC, Brandao 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.
PubMed 26106207Ari 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.
PubMed 20587095Dugernier 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.
PubMed 25393556Lin 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.
PubMed 19796413Ari 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.
PubMed 20587094Dugernier 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.
PubMed 27447788Ehrmann S, Roche-Campo F, Bodet-Contentin L, Razazi K, Dugernier J, Trenado-Alvarez J, Donzeau A, Vermeulen F, Thevoz 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.
PubMed 26602786
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerosol Therapy in Intensive Care Units: a Prospective Observation Study
- ClinicalTrials.gov ID
- NCT03597334
- Acronym / sponsor ID
- ATICU / PekingUPH-lvshan
- Conditions
- Respiration, Artificial, Critical Care
- Keywords
- administration,inhalation, metered dose inhalers, nebulizers and vaporizers, bronchodilator agents, anti-bacterial agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,095 participants (actual)
- Lead sponsor
- lvshanUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 5 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critical ill patients | – | Behavioral: aerosol therapycritical ill patients who admit to ICU |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients present in intensive care unit during the study period
Key inclusion criteria (1 listed)
- patients present in intensive care unit during the study period
Key exclusion criteria (1 listed)
- patients refuse to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerosol therapyAerosol 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 | Behavioural | critical ill patients |
Primary outcome
Frequency of aerosol therapy
Time frame: 2 weeks
how many aerosol therapy be administered in ICU patients
5 secondary outcomes
drugs of aerosol therapy
Time frame: 2 weeks
Side effects of aerosol therapy
Time frame: 2 weeeks
selection of the aerosol device
Time frame: 2 weeeks
aerosol device's installation position
Time frame: 2 weeeks
humidification condition during aerosol therapy
Time frame: 2 weeeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Background: PubMed 26070580Ari A. Aerosol Therapy in Pulmonary Critical Care. Respir Care. 2015 Jun;60(6):858-74; discussion 874-9. doi: 10.4187/respcare.03790.
- Background: PubMed 27716346Dhanani 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. doi: 10.1186/s13054-016-1448-5.
- Background: PubMed 26152470Ari 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.
- Background: PubMed 27822851Dugernier 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.
- Background: PubMed 26106207Galindo-Filho VC, Ramos ME, Rattes CS, Barbosa AK, Brandao DC, Brandao 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.
- Background: PubMed 20587095Ari 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.
- Background: PubMed 25393556Dugernier 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.
- Background: PubMed 19796413Lin 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.
- Background: PubMed 20587094Ari 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.
- Background: PubMed 27447788Dugernier 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.
- Background: PubMed 26602786Ehrmann S, Roche-Campo F, Bodet-Contentin L, Razazi K, Dugernier J, Trenado-Alvarez J, Donzeau A, Vermeulen F, Thevoz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shan Lyu, Bacelor principal investigator
Peking University People's hospital ,beijing ,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration, Artificial and Critical Care, run by lvshan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of aerosol therapy (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03597334, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.