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Breath Actuated Nebulizer Study Protocol

Primary Purpose

Asthma, Chronic Obstructive Pulmonary Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard nebulizer
breath actuated nebulizer
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring breath actuated nebulizer, nebulizer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Christiana Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Standard nebulizer versus standard breath actuated nebulizer

Outcomes

Primary Outcome Measures

Forced vital capacity
FEV1

Secondary Outcome Measures

Full Information

First Posted
September 27, 2006
Last Updated
December 12, 2012
Sponsor
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT00382447
Brief Title
Breath Actuated Nebulizer Study Protocol
Official Title
Breath Actuated Nebulizer Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to put forth the human resources for patient enrollment
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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 intensive care unit (ICU) or Emergency Department. Protocol: Adult patient ordered for Q4 to Q6 2.5 mg albuterol sulfate nebulizer therapy with or without anticholinergic agent (ipratropium/tiotropium) Patient is consented Patient is randomized to receive either "Control Method" or "Study Method" first (see methods below) The 1st morning after consent, the first study method is used The 2nd morning after consent, the other study method is used Study is over after the second study method is completed Control Method: Baseline patient data with spirometry is recorded including: Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1),Forced Expiratory Ratio (FER), Peak Expiratory Flow (PEF), HR, Resting RR, Breath sounds, Pulse Oximetry (SpO2). 2.5 mg albuterol sulfate is given with generic nebulizer for the 0700 treatment time. Anticholinergic agents such as ipratropium or tiotropium are given as ordered. Follow-up patient data with spirometry is recorded at 15 minutes and 2 hours following the treatment. Subsequent treatments that day are given as standard. Study Method: Baseline patient data with spirometry is recorded including: Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1),Forced Expiratory Ratio (FER), Peak Expiratory Flow (PEF), Heart rate (HR), Resting respiratory rate (RR), Breath sounds, Pulse Oximetry (SpO2). Albuterol sulfate (2.5 mg) is given via Aero Eclipse BAN with 0.5 ml of saline or 0.5 ml of ipratropium bromide (if ipratropium bromide is ordered). Follow-up patient data with spirometry is recorded at 15 minutes and 2 hours following the treatment. Subsequent treatments that day are given as ordered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Obstructive Pulmonary Disease
Keywords
breath actuated nebulizer, nebulizer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Standard nebulizer versus standard breath actuated nebulizer
Intervention Type
Device
Intervention Name(s)
standard nebulizer
Intervention Description
Standard small volume nebulizer for aerosolized medication delivery
Intervention Type
Device
Intervention Name(s)
breath actuated nebulizer
Intervention Description
Nebulizer that dispenses medication only during the inspiratory phase
Primary Outcome Measure Information:
Title
Forced vital capacity
Time Frame
1
Title
FEV1
Time Frame
1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S. Emberger, BS
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States

12. IPD Sharing Statement

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Breath Actuated Nebulizer Study Protocol

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