NCT01935388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

2.7 years

First QC Date

July 31, 2013

Last Update Submit

October 6, 2016

Conditions

Ventilator Associated Pneumonia

Keywords

Mechanical ventilationchronic obstructive pulmonary diseaseasthmacommon canisterMDIventilator associated pneumonia

Outcome Measures

Primary Outcomes (1)

  • Ventilator-associated pneumonia (VAP)

    Pneumonia that developed in association with mechanical ventilation

    48 hours after intubation

Secondary Outcomes (1)

  • Inhaler drug cost

    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.

Study Arms (2)

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.

Other: Common canister

Control

NO INTERVENTION

Each patient will be assigned an individual inhaler as per standard of care practice.

Interventions

Common canisterOTHER

Drug administration via a shared canister with a standardized cleaning protocol.

Common canister

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • lung transplant
  • neutropenic
  • contact isolation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • 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.

    PMID: 27143787DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedPulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveChronic DiseaseBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Marin Kollef, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 31, 2013

First Posted

September 5, 2013

Study Start

June 1, 2013

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

October 7, 2016

Record last verified: 2016-10

Locations

US(1)