Breath Actuated Nebulizer Study Protocol

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease; Asthma
• Intervention / Treatment: Device: standard nebulizer; Device: breath actuated 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:

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Standard nebulizer versus standard breath actuated nebulizer	Device: standard nebulizer; Standard small volume nebulizer for aerosolized medication delivery; Device: breath actuated nebulizer; Nebulizer that dispenses medication only during the inspiratory phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Forced vital capacity	1
FEV1	1

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Investigators: Principal Investigator: John S. Emberger, BS, Christiana Care Health Services

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: September 27, 2006
• First Submitted That Met QC Criteria: September 27, 2006
• First Posted (Estimate): September 29, 2006

Study Record Updates

• Last Update Posted (Estimate): December 13, 2012
• Last Update Submitted That Met QC Criteria: December 12, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: nebulizer; breath actuated nebulizer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CCC# 26168