Common Canister Protocol for Inhaler Administration in Mechanically Ventilated Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dr. Marin Kollef, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01935388
First received: July 31, 2013
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Ventilator Associated Pneumonia
Other: Common canister
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Common Canister Protocol for Metered Dose Inhaler Administration in Mechanically Ventilated Patients

Resource links provided by NLM:


Further study details as provided by Barnes-Jewish Hospital:

Primary Outcome Measures:
  • Ventilator-associated pneumonia (VAP) [ Time Frame: 48 hours after intubation ] [ Designated as safety issue: Yes ]
    Pneumonia that developed in association with mechanical ventilation


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Inhaler charges accrued during mechanical ventilation


Estimated Enrollment: 258
Study Start Date: June 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr. Marin Kollef, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01935388     History of Changes
Other Study ID Numbers: BJH CCP
Study First Received: July 31, 2013
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Barnes-Jewish Hospital:
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

ClinicalTrials.gov processed this record on August 21, 2014