Ventilator Associated PneumoniaPhase 4NCT01935388
Common Canister Protocol for Inhaler Administration in Mechanically Ventilated Patients
A Phase 4 study testing Common canister in people with Ventilator Associated Pneumonia, run by Barnes-Jewish Hospital at 1 site in United States.
Trial summary
Many hospitals employ a common canister inhaler protocol in patients that do not require mechanical ventilator support. Common canister refers to a single inhaler paired with standardized cleaning methods for use on more than one patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Common canister
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Mar 2016
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mechanically ventilated patients prescribed bronchodilator therapy in a medical intensive care unit
Who cannot join
- lung transplant
- neutropenic
- contact isolation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Common Canister Protocol for Metered Dose Inhaler Administration in Mechanically Ventilated Patients
Many hospitals employ a common canister inhaler protocol in patients that do not require mechanical ventilator support. Common canister refers to a single inhaler paired with standardized cleaning methods for use on more than one patient. Small reports suggest that this method does not pose an increased infectious risk and is associated with significant cost savings.
Common canister protocols offer a solution to the discordance between inhaler sizes and average inpatient use of the drugs. Metered dose inhaler canisters are contain enough drug for several days to weeks of daily use. However, the average length of stay for most inpatients is only several days. Therefore, most inpatients do not use all of the canister contents, an unused resource that is potentially wasted.
The common canister approach has not been previously described in mechanically ventilated patients (people requiring intensive care unit admission on breathing machines). This study aims to assess the safety of common canister utilization by assessment and comparison of infection rates in the study and control group.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Common canister
- Keywords
- Mechanical ventilation, chronic obstructive pulmonary disease, asthma, common canister, MDI, ventilator associated pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common canisterOther
Drug administration via a shared canister with a standardized cleaning protocol.
| Study group | Role | What they receive |
|---|---|---|
| Common canister | Experimental | Use of a single MDI (instead of assigning each patient an individual MDI) for multiple mechanically ventilated patients. Inhalers will undergo a stringent cleaning protocol between administrations and storage. Receives: Other: Common canister |
| Control | No intervention | Each patient will be assigned an individual inhaler as per standard of care practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-associated pneumonia (VAP)
Pneumonia that developed in association with mechanical ventilation
Measured: 48 hours after intubation
Secondary outcomes (1)
Inhaler drug cost
Inhaler charges accrued during mechanical ventilation
Measured: During period of mechanical ventilation, which varies depending on patient's severity of illness and reason for intubation; on average may range from 3-5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barnes-Jewish Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peggy Watts, Washington University School of Medicine
- Investigators
- Marin Kollef, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935388
- Sponsor's protocol ID
- BJH CCP
- Status last verified
- Oct 2016
- First submitted
- 31 Jul 2013
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gowan M, Bushwitz J, Watts P, Silver PC, Jackson M, Hampton N, Kollef MH. Use of a Shared Canister Protocol for the Delivery of Metered-Dose Inhalers in Mechanically Ventilated Subjects. Respir Care. 2016 Oct;61(10):1285-92. doi: 10.4187/respcare.04550. Epub 2016 May 3.
PubMed 27143787
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Canister Protocol for Metered Dose Inhaler Administration in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT01935388
- Acronym / sponsor ID
- BJH CCP
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Mechanical ventilation, chronic obstructive pulmonary disease, asthma, common canister, MDI, ventilator associated pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Barnes-Jewish HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Sep 2013 (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.
Many hospitals employ a common canister inhaler protocol in patients that do not require mechanical ventilator support. Common canister refers to a single inhaler paired with standardized cleaning methods for use on more than one patient. Small reports suggest that this method does not pose an increased infectious risk and is associated with significant cost savings.
Common canister protocols offer a solution to the discordance between inhaler sizes and average inpatient use of the drugs. Metered dose inhaler canisters are contain enough drug for several days to weeks of daily use. However, the average length of stay for most inpatients is only several days. Therefore, most inpatients do not use all of the canister contents, an unused resource that is potentially wasted.
The common canister approach has not been previously described in mechanically ventilated patients (people requiring intensive care unit admission on breathing machines). This study aims to assess the safety of common canister utilization by assessment and comparison of infection rates in the study and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common canister | Experimental | Other: Common canisterUse of a single MDI (instead of assigning each patient an individual MDI) for multiple mechanically ventilated patients. Inhalers will undergo a stringent cleaning protocol between administrations and storage. |
| Control | No intervention | –Each patient will be assigned an individual inhaler as per standard of care practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mechanically ventilated patients prescribed bronchodilator therapy in a medical intensive care unit
Key exclusion criteria (3 listed)
- lung transplant
- neutropenic
- contact isolation
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 |
|---|---|---|
| Common canisterDrug administration via a shared canister with a standardized cleaning protocol. | Other | Common canister |
Primary outcome
Ventilator-associated pneumonia (VAP)
Time frame: 48 hours after intubation
Pneumonia that developed in association with mechanical ventilation
1 secondary outcome
Inhaler drug cost
Time frame: During period of mechanical ventilation, which varies depending on patient's severity of illness and reason for intubation; on average may range from 3-5 days.
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 7 Oct 2016.
- Derived from this study: PubMed 27143787Gowan M, Bushwitz J, Watts P, Silver PC, Jackson M, Hampton N, Kollef MH. Use of a Shared Canister Protocol for the Delivery of Metered-Dose Inhalers in Mechanically Ventilated Subjects. Respir Care. 2016 Oct;61(10):1285-92. doi: 10.4187/respcare.04550. Epub 2016 May 3.
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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.
Marin Kollef, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Common canister in people with Ventilator Associated Pneumonia, run by Barnes-Jewish Hospital at 1 site in United States.
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 3 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 7 Oct 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Ventilator-associated pneumonia (VAP) (time frame: 48 hours after intubation). 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 NCT01935388, which also lists 1 linked publication.
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 7 Oct 2016.