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This study has been withdrawn prior to enrollment.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

September 27, 2006
December 12, 2012
October 2006
June 2008   (final data collection date for primary outcome measure)
  • Forced vital capacity [ Time Frame: 1 ] [ Designated as safety issue: Yes ]
  • FEV1 [ Time Frame: 1 ] [ Designated as safety issue: Yes ]
  • FEV1
  • Forced Vital Capacity
  • Peak Expiratory Flow Rate
  • Heart Rate
  • Resting Respiratory Rate
  • Breath sounds
  • SpO2
  • Treatment Time
Complete list of historical versions of study NCT00382447 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Breath Actuated Nebulizer Study Protocol
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Asthma
  • Chronic Obstructive Pulmonary Disease
  • Device: standard nebulizer
    Standard small volume nebulizer for aerosolized medication delivery
  • Device: breath actuated nebulizer
    Nebulizer that dispenses medication only during the inspiratory phase
Experimental: 1
Standard nebulizer versus standard breath actuated nebulizer
Interventions:
  • Device: standard nebulizer
  • Device: breath actuated nebulizer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00382447
CCC# 26168
Yes
Christiana Care Health Services
Christiana Care Health Services
Not Provided
Principal Investigator: John S. Emberger, BS Christiana Care Health Services
Christiana Care Health Services
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP