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Clinical Trials/NCT00382447
NCT00382447WithdrawnNot Applicable

Breath Actuated Nebulizer Study Protocol

Christiana Care Health Services2 sites in 1 countryStarted: October 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
2
Primary Endpoint
Forced vital capacity

Study Overview

Brief Summary

Comparison of the researchers' standard nebulizer and a breath actuated nebulizer to examine if breathing medication can be delivered more quickly and as effectively or more effectively than the standard nebulizer.

Detailed Description

Background:

Generic nebulizers as well as breath actuated nebulizers have been available and FDA approved to administer therapy for years. Recently there has been interest in using breath actuated nebulizers to stream-line patient care in the hospital setting. Literature has found that breath actuated nebulizers are not only faster at delivering an equivalent dose, but more effective when measuring patient response to that therapy. There is no standard for method of converting from generic nebulizers to breath actuated technology.

Objectives:

We want to evaluate the use of Breath Actuated Nebulizer (BAN) technology versus generic nebulizers to improve quality of patient treatments and reduce nebulization duration to allow staff time to do complete patient assessments.

Inclusion Criteria:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult patients with orders for routine 2.5 mg albuterol sulfate nebulizer therapy ordered either Q4 or Q6 hours who consent to the study.

Exclusion Criteria

  • Adults with nebulizer therapy ordered more frequently than Q4 hours.
  • Adults with nebulizer therapy ordered less frequently than Q6 hours.
  • Pregnant patients are excluded.
  • Adults with orders for albuterol sulfate > 2.5 mg.
  • Adults in the ICU or Emergency Department.

Outcomes

Primary Outcomes

Forced vital capacity

Time Frame: 1

FEV1

Time Frame: 1

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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