Common Canister Protocol for Inhaler Administration in Mechanically Ventilated Patients

NCT ID: NCT01935388

Last Updated: 2016-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-03-31

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.

Conditions

Ventilator Associated Pneumonia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Common canister

Intervention Type: OTHER

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Common canister

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• lung transplant
• neutropenic
• contact isolation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barnes-Jewish Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peggy Watts

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marin Kollef, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Barnes-Jewish Hospital

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27143787 (View on PubMed)

Other Identifiers

BJH CCP

Identifier Type: -

Identifier Source: org_study_id