Respiratory FailureNCT02987036
Delivery of Beta Agonists is Technique Sensitive (DOBATS)Mechanics
A study testing Aerogen and Jet nebulizer in people with Respiratory Failure, run by Southeast University, China at 1 site in China.
Trial summary
The purpose of this study is to find out weather differences in administration nebulizer technology (Jet nebulizer VS. mesh nebulizer) will have impact on lung mechanic variables (Compliance, resistance and PEEPi) during controlled mechanical ventilation. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Aerogen and Jet nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Nov 2016
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients on mechanical ventilation for more than 48 hours
- PEEPi ≥3 cm H2O and expected to remain on controlled mechanical ventilation for at least 24 hours.
Who cannot join
- Severe chronic lung disease with chronic hypercapnia (PCO2>45 mm Hg), Chronic hypoxemia (PO2< 55mm Hg with FiO2=0,21), hospitalization within last 6 months for respiratory failure (PCO2>50; PO2<55mm Hg), Secondary polycythemia, severe pulmonary hypertension (mPAP >40 mm Hg.
- Unable to obtain consent
- Acute myocardial infarction
- Severe congestive heart failure
- Heart rate greater than maximal predicted heart rate MHR85 (MHR 85=0.85 x (220-age).
- Burns over more than 40% of body surface area
Show all 16Show fewer
- Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
- Allogenic bone marrow transplantation within 5 years prior to the study
- Diffuse alveolar hemorrhage from vaculitis
- Morbid obesity
- Moribund, not expected to survive 24 hours
- Daily use of beta agonists prior to hospitalization
- Participation in other study
- Chronic liver disease
- Neuromuscular disease that impairs ability to breath without assistance (e.g. Cervical spine cord injury at level C5 and higher, Amyotrophic lateral sclerosis, Guillain-Barre syndrome or myasthenia gravis)
- Pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of Beta-agonistic Drug Using Two Different Nebulizer Technologies: Effects on Lung Mechanics
The purpose of this study is to find out weather differences in administration nebulizer technology (Jet nebulizer VS. mesh nebulizer) will have impact on lung mechanic variables (Compliance, resistance and PEEPi) during controlled mechanical ventilation.
Read the detailed description
The delivery of aerosols has a two fold appeal as it is distributed direct to the tracheo- bronchial tree and alveolar epithelium. The drug is then rapidly absorbed by the circulation avoiding the first pass entero-hepatic metabolic effect.
The systemic effects may be regarded as a side effect in the case were the primary therapeutic target is aimed at the bronchial tree as is the case with broncho-active drugs, such as β2-stimulants.
The ability of particles to remain suspended in a gas can be predicted from their size, shape and density, coupled with the density and viscosity of the gas. The properties of an aerosol is commonly expressed as the Mass Median Aerosol Diameter MMAD, a measure of the average particle size and the geometric standard deviation. It is calculated from the cumulative particle size curve1. The MMAD will give a reliable estimate of the likely deposition of the drug along the tracheo-bronchial tree. A particle size >5 will likely deposit in the upper airways, while particles with an MMAD of 2-5 is likely to deposit in the tracheo-bronchial tree2.
Jet nebulizers are the most commonly used devices for aerosol therapy. However, the MMAD generated by this device is unpredictable, often leading to the drug being deposited in the ventilator circuit or endotracheal tube3.
An alternative is the vibrating mesh nebulizer, which is based on a high frequency vibrating piezoelectric crystal. The crystal will vibrate a micron mesh at a very high frequency. A micro pump will deliver a small volume of liquid from a reservoir into the vibrating mesh resulting in a very precise aerosol generation3.
Nebulizer therapy is often prescribed without proven effects or proper evaluation of result. Indeed, two large multicenter trial in acute lung injury patients were discontinued at interim analyses due to lack of effect4,5. This lack of effect may be due to the nebulizer technology (Jet nebulizer), the indication (ARDS), or primary outcome.
The investigators would like to compare the difference in therapeutic effect between these two devices as this has not been published previously. It is well known that the physical properties of the generated aerosol may differ widely, depending on device and technology used. Hence, even if the same amount of drug is administered, distribution and uptake will not be the same. It can further be expected that the therapeutic response will be different.
- Conditions
- Respiratory Failure
- Being tested
- Aerogen, Jet nebulizer
- Keywords
- nebulizer technologies, lung mechanics, beta-agonistic drug
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AerogenDevice
Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by mesh nebulizer
Jet nebulizerDevice
Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Jet nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Aerogen | Experimental | Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Aerogen Receives: Device: Aerogen |
| Jet Nebulizer | Other | Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Jet Nebulizer Receives: Device: Jet nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of intrinsi PPPE
Measured: 0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration
Secondary outcomes (2)
change of respioratory resistance
Measured: 0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration
change of respiratory system Compliance
Measured: 0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Ling Ling, Dr, Study director, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987036
- Sponsor's protocol ID
- nebulizer
- Status last verified
- Dec 2016
- First submitted
- 13 Jan 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Beta-agonistic Drug Using Two Different Nebulizer Technologies: Effects on Lung Mechanics
- ClinicalTrials.gov ID
- NCT02987036
- Acronym / sponsor ID
- nebulizer
- Conditions
- Respiratory Failure
- Keywords
- nebulizer technologies, lung mechanics, beta-agonistic drug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Dec 2016 (estimated)
- 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.
The purpose of this study is to find out weather differences in administration nebulizer technology (Jet nebulizer VS. mesh nebulizer) will have impact on lung mechanic variables (Compliance, resistance and PEEPi) during controlled mechanical ventilation.
Detailed description
The delivery of aerosols has a two fold appeal as it is distributed direct to the tracheo- bronchial tree and alveolar epithelium. The drug is then rapidly absorbed by the circulation avoiding the first pass entero-hepatic metabolic effect.
The systemic effects may be regarded as a side effect in the case were the primary therapeutic target is aimed at the bronchial tree as is the case with broncho-active drugs, such as β2-stimulants.
The ability of particles to remain suspended in a gas can be predicted from their size, shape and density, coupled with the density and viscosity of the gas. The properties of an aerosol is commonly expressed as the Mass Median Aerosol Diameter MMAD, a measure of the average particle size and the geometric standard deviation. It is calculated from the cumulative particle size curve1. The MMAD will give a reliable estimate of the likely deposition of the drug along the tracheo-bronchial tree. A particle size >5 will likely deposit in the upper airways, while particles with an MMAD of 2-5 is likely to deposit in the tracheo-bronchial tree2.
Jet nebulizers are the most commonly used devices for aerosol therapy. However, the MMAD generated by this device is unpredictable, often leading to the drug being deposited in the ventilator circuit or endotracheal tube3.
An alternative is the vibrating mesh nebulizer, which is based on a high frequency vibrating piezoelectric crystal. The crystal will vibrate a micron mesh at a very high frequency. A micro pump will deliver a small volume of liquid from a reservoir into the vibrating mesh resulting in a very precise aerosol generation3.
Nebulizer therapy is often prescribed without proven effects or proper evaluation of result. Indeed, two large multicenter trial in acute lung injury patients were discontinued at interim analyses due to lack of effect4,5. This lack of effect may be due to the nebulizer technology (Jet nebulizer), the indication (ARDS), or primary outcome.
The investigators would like to compare the difference in therapeutic effect between these two devices as this has not been published previously. It is well known that the physical properties of the generated aerosol may differ widely, depending on device and technology used. Hence, even if the same amount of drug is administered, distribution and uptake will not be the same. It can further be expected that the therapeutic response will be different.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerogen | Experimental | Device: AerogenTwo doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Aerogen |
| Jet Nebulizer | Other | Device: Jet nebulizerTwo doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Jet Nebulizer |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients on mechanical ventilation for more than 48 hours
- PEEPi ≥3 cm H2O and expected to remain on controlled mechanical ventilation for at least 24 hours.
Key exclusion criteria (16 listed)
- Severe chronic lung disease with chronic hypercapnia (PCO2>45 mm Hg), Chronic hypoxemia (PO2< 55mm Hg with FiO2=0,21), hospitalization within last 6 months for respiratory failure (PCO2>50; PO2<55mm Hg), Secondary polycythemia, severe pulmonary hypertension (mPAP >40 mm Hg.
- Unable to obtain consent
- Acute myocardial infarction
- Severe congestive heart failure
- Heart rate greater than maximal predicted heart rate MHR85 (MHR 85=0.85 x (220-age).
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 |
|---|---|---|
| AerogenTwo doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by mesh nebulizer | Device | Aerogen |
| Jet nebulizerTwo doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Jet nebulizer | Device | Jet Nebulizer |
Primary outcome
change of intrinsi PPPE
Time frame: 0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration
2 secondary outcomes
change of respioratory resistance
Time frame: 0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration
change of respiratory system Compliance
Time frame: 0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration
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 8 Dec 2016.
- 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.
Ling Ling, Dr study director
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerogen and Jet nebulizer in people with Respiratory Failure, run by Southeast University, China 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 2 inclusion and 16 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 8 Dec 2016. 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?
change of intrinsi PPPE (time frame: 0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2016.