Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382447
Status:
WITHDRAWN
Last Update Posted:
2012-12-13
First Post:
2006-09-27
Brief Title:
Breath Actuated Nebulizer Study Protocol
Sponsor:
Christiana Care Health Services
Organization:
Christiana Care Health Services
Study Overview
Official Title:
Breath Actuated Nebulizer Study Protocol
Status:
WITHDRAWN
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to put forth the human resources for patient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25 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 25 mg
Adults in the intensive care unit ICU or Emergency Department
Protocol
1 Adult patient ordered for Q4 to Q6 25 mg albuterol sulfate nebulizer therapy with or without anticholinergic agent ipratropiumtiotropium
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 FEV1Forced Expiratory Ratio FER Peak Expiratory Flow PEF HR Resting RR Breath sounds Pulse Oximetry SpO2
2 25 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 FEV1Forced Expiratory Ratio FER Peak Expiratory Flow PEF Heart rate HR Resting respiratory rate RR Breath sounds Pulse Oximetry SpO2
2 Albuterol sulfate 25 mg is given via Aero Eclipse BAN with 05 ml of saline or 05 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
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 25 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 25 mg
Adults in the intensive care unit ICU or Emergency Department
Protocol
1 Adult patient ordered for Q4 to Q6 25 mg albuterol sulfate nebulizer therapy with or without anticholinergic agent ipratropiumtiotropium
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 FEV1Forced Expiratory Ratio FER Peak Expiratory Flow PEF HR Resting RR Breath sounds Pulse Oximetry SpO2
2 25 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 FEV1Forced Expiratory Ratio FER Peak Expiratory Flow PEF Heart rate HR Resting respiratory rate RR Breath sounds Pulse Oximetry SpO2
2 Albuterol sulfate 25 mg is given via Aero Eclipse BAN with 05 ml of saline or 05 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None