A Real Life Evaluation of the Performance of a Large Volume Nebulizer

NCT ID: NCT00632112

Last Updated: 2009-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Brief Summary

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Continuous albuterol has become the standard of care for patients in status asthmaticus. We have previously performed an in-vitro study comparing 4 different brands of continuous nebulizers. We now want to compare the in-vitro with the in-vivo performance of the brand we use. we hypothesize that there will be no difference between in-vivo and in-vitro results.

Detailed Description

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There will be no intervention to the patients. Nebulizers will be used as per current policies and procedures. They will only be marked on the outside at the water level every 2 hours for the first 6 hours. Once ready to be discarded will be collected for laboratory testing Once in the laboratory, nebulizers will be weight on a precision scale without liquid, then they will be filled with normal saline to the first mark (6th hour) and re-weight. The nebulizers will be filled to next mark and re-weight until 200 mls. of total volume are achieved. Solution output will be calculated as the weight difference between the 2 hour periods.

Conditions

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Asthma

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients admitted to Pediatric Intensive Care Unit due to status asthmaticus, requiring continuous albuterol nebulization.

Exclusion Criteria

* Patients requiring invasive or non-invasive ventilation.
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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S&T Medical Technologies, Inc.

INDUSTRY

Sponsor Role collaborator

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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University of Arkansas for Medical Sciences

Principal Investigators

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Ariel Berlinski, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ariel Berlinski, M.D.

Role: CONTACT

501-364-1006

Facility Contacts

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Ariel Berlinski, M.D.

Role: primary

501-364-1006

Other Identifiers

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98551

Identifier Type: -

Identifier Source: org_study_id

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