Common Canister Protocol for Inhaler Administration in Mechanically Ventilated Patients

Ventilator Associated Pneumonia Clinical Trial

Official title:

Common Canister Protocol for Metered Dose Inhaler Administration in Mechanically Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935388
• Other study ID #: BJH CCP
• Status: Completed
• Phase: Phase 4
• First received: July 31, 2013
• Last updated: October 6, 2016
• Start date: June 2013
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: Barnes-Jewish Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• lung transplant

• neutropenic

• contact isolation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Other:
• Common canister
Drug administration via a shared canister with a standardized cleaning protocol.

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-associated pneumonia (VAP)	Pneumonia that developed in association with mechanical ventilation	48 hours after intubation	Yes
Secondary	Inhaler drug cost	Inhaler charges accrued during mechanical ventilation	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.	No