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Common Canister Protocol for Inhaler Administration in Mechanically Ventilated Patients

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ClinicalTrials.gov Identifier: NCT01935388
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Peggy Watts, Washington University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Other: Common canister Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Common Canister Protocol for Metered Dose Inhaler Administration in Mechanically Ventilated Patients
Study Start Date : June 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Common canister
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.
Other: Common canister
Drug administration via a shared canister with a standardized cleaning protocol.

No Intervention: Control
Each patient will be assigned an individual inhaler as per standard of care practice.



Primary Outcome Measures :
  1. Ventilator-associated pneumonia (VAP) [ Time Frame: 48 hours after intubation ]
    Pneumonia that developed in association with mechanical ventilation


Secondary Outcome Measures :
  1. 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. ]
    Inhaler charges accrued during mechanical ventilation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mechanically ventilated patients prescribed bronchodilator therapy in a medical intensive care unit

Exclusion Criteria:

  • lung transplant
  • neutropenic
  • contact isolation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935388


Locations
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Barnes-Jewish Hospital
Investigators
Principal Investigator: Marin Kollef, MD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peggy Watts, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01935388     History of Changes
Other Study ID Numbers: BJH CCP
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016

Keywords provided by Peggy Watts, Washington University School of Medicine:
Mechanical ventilation
chronic obstructive pulmonary disease
asthma
common canister
MDI
ventilator associated pneumonia

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury