Breath Actuated Nebulizer Study Protocol

This study has been withdrawn prior to enrollment.
(Unable to put forth the human resources for patient enrollment)
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00382447
First received: September 27, 2006
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Asthma
Chronic Obstructive Pulmonary Disease
Device: standard nebulizer
Device: breath actuated nebulizer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Breath Actuated Nebulizer Study Protocol

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Forced vital capacity [ Time Frame: 1 ] [ Designated as safety issue: Yes ]
  • FEV1 [ Time Frame: 1 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: October 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Hide Detailed Description

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382447

Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: John S. Emberger, BS Christiana Care Health Services
  More Information

No publications provided

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00382447     History of Changes
Other Study ID Numbers: CCC# 26168
Study First Received: September 27, 2006
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
breath actuated nebulizer
nebulizer

Additional relevant MeSH terms:
Asthma
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014