View Clinical Trial (Medical Research Study)
Vapotherm High Flow Therapy Via Nasal Cannula to Treat Respiratory Insufficiency in Patients With Chronic Obstructive Pulmonary Disease
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19140 |
| Conditions: |
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Pulmonary Disease, Chronic Obstructive - Respiratory Insufficiency |
| Purpose: |
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The aim of this study is to see if the Vapotherm High Flow Therapy (HFT) device is effective
to provide breathing support to patients with Chronic Obstructive Pulmonary Disease or COPD.
The investigators believe that patients using HFT will not require as much use of therapies
that provide pressure through a face mask, and are already recognized by FDA as support
therapies for respiratory insufficiency.
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| Study Summary: |
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The overall objective of this study is to demonstrate that Vapotherm High Flow Therapy (HFT)
via nasal cannula provides respiratory support to patients with COPD as a primary diagnosis,
who present with respiratory insufficiency in the Emergency Department. We intend to
demonstrate that Vapotherm HFT via nasal cannula will result in at least equivalent patient
outcomes as the current standard of care, while eliminating the need for other non-invasive
respiratory support devices cleared for the treatment of respiratory insufficiency. The
current standard of care will include the use of other devices cleared by the FDA as
respiratory assist devices for the treatment of adult respiratory insufficiency.
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| Criteria: |
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Inclusion Criteria:
- Present to the Emergency Department with a history of COPD and with symptoms
consistent with a diagnosis of respiratory insufficiency and exacerbation of COPD
- Must be hemodynamically stable as judged by treating clinician in the ED
- Primary complaint is shortness of breath, and presumed diagnosis is exacerbation of
COPD
Exclusion Criteria:
- Fever
- Radiographic evidence of pneumonia
- Glasgow Coma score < 14 or unable to correctly answer at least one study-specific
question
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| NCT ID: |
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NCT00990119 |
| Primary Contact: |
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Principal Investigator
Marla R Wolfson, PhD
Temple University
Marla R Wolfson, PhD
Phone: 215-707-4573
Email: marla.wolfson@temple.edu
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| Backup Contact: |
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Email: ngentile@temple.edu
Nina Gentile, MD
Phone: (215) 707-8402
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| Location Contact: |
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Philadelphia, Pennsylvania 19140
United States
Marla R Wolfson, PhD
Phone: 215-707-4573
Email: marla.wolfson@temple.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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