Breath Actuated Nebulizer Study Protocol

Asthma Clinical Trial

Official title:

Breath Actuated Nebulizer Study Protocol

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00382447
• Other study ID #: CCC# 26168
• Status: Withdrawn
• Phase: N/A
• First received: September 27, 2006
• Last updated: December 12, 2012
• Start date: October 2006
• Est. completion date: June 2008

Study information

• Verified date: December 2012
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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:

1. Adult patient ordered for Q4 to Q6 2.5 mg albuterol sulfate nebulizer therapy with or without anticholinergic agent (ipratropium/tiotropium)

2. Patient is consented

3. Patient is randomized to receive either "Control Method" or "Study Method" first (see methods below)

4. The 1st morning after consent, the first study method is used

5. The 2nd morning after consent, the other study method is used

6. Study is over after the second study method is completed

Control Method:

1. 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. 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.

3. Follow-up patient data with spirometry is recorded at 15 minutes and 2 hours following the treatment.

4. Subsequent treatments that day are given as standard.

Study Method:

1. 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).

2. 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).

3. Follow-up patient data with spirometry is recorded at 15 minutes and 2 hours following the treatment.

4. Subsequent treatments that day are given as ordered.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• standard nebulizer
Standard small volume nebulizer for aerosolized medication delivery
• breath actuated nebulizer
Nebulizer that dispenses medication only during the inspiratory phase

Locations

Country	Name	City	State
United States	Christiana Hospital	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced vital capacity		1	Yes
Primary	FEV1		1	Yes