Clinical trial NCT00382447: Breath Actuated Nebulizer Study Protocol
Official title: Breath Actuated Nebulizer Study Protocol
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Keywords: breath actuated nebulizer
nebulizer
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2006-09-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.

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.

Primary outcomes:
measure: Forced vital capacity
timeFrame: 1
measure: FEV1
timeFrame: 1
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: John S. Emberger, BS
role: PRINCIPAL_INVESTIGATOR
References: