Back to resultsCommon Canister Protocol for Inhaler Administration in Mechanically Ventilated Patients
Primary Purpose
Ventilator Associated Pneumonia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Common canister
Sponsored by
About this trial
This is an interventional treatment trial for Ventilator Associated Pneumonia focused on measuring Mechanical ventilation, chronic obstructive pulmonary disease, asthma, common canister, MDI, ventilator associated pneumonia
Eligibility Criteria
Inclusion Criteria:
- mechanically ventilated patients prescribed bronchodilator therapy in a medical intensive care unit
Exclusion Criteria:
- lung transplant
- neutropenic
- contact isolation
Sites / Locations
- Barnes-Jewish Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Common canister
Control
Arm Description
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.
Each patient will be assigned an individual inhaler as per standard of care practice.
Outcomes
Primary Outcome Measures
Ventilator-associated pneumonia (VAP)
Pneumonia that developed in association with mechanical ventilation
Secondary Outcome Measures
Inhaler drug cost
Inhaler charges accrued during mechanical ventilation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01935388
Brief Title
Common Canister Protocol for Inhaler Administration in Mechanically Ventilated Patients
Official Title
Common Canister Protocol for Metered Dose Inhaler Administration in Mechanically Ventilated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barnes-Jewish Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia
Keywords
Mechanical ventilation, chronic obstructive pulmonary disease, asthma, common canister, MDI, ventilator associated pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
354 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Common canister
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Each patient will be assigned an individual inhaler as per standard of care practice.
Intervention Type
Other
Intervention Name(s)
Common canister
Intervention Description
Drug administration via a shared canister with a standardized cleaning protocol.
Primary Outcome Measure Information:
Title
Ventilator-associated pneumonia (VAP)
Description
Pneumonia that developed in association with mechanical ventilation
Time Frame
48 hours after intubation
Secondary Outcome Measure Information:
Title
Inhaler drug cost
Description
Inhaler charges accrued during mechanical ventilation
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mechanically ventilated patients prescribed bronchodilator therapy in a medical intensive care unit
Exclusion Criteria:
lung transplant
neutropenic
contact isolation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marin Kollef, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27143787
Citation
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.
Results Reference
derived
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Common Canister Protocol for Inhaler Administration in Mechanically Ventilated Patients
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