Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Vapotherm High Flow Therapy Via Nasal Cannula to Treat Respiratory Insufficiency in Patients With Chronic Obstructive Pulmonary Disease
Verified date | September 2020 |
Source | Vapotherm, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Temple University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Vapotherm, Inc. |
United States,
Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV) | While in Emergency Department; at 24 hrs | ||
Secondary | Borg Dyspnea Scale | 0, 2, 4 hrs | ||
Secondary | Respiratory Rate | 0, 2, 4 hrs | ||
Secondary | Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE- | 0, 2, 4 hrs | ||
Secondary | Pulse Ox and FIO2 | 0, 2, 4 hrs | ||
Secondary | Intensive Care Unit admission rate / Length of Stay | 7 days | ||
Secondary | Hospital Length of Stay | 7 days | ||
Secondary | Total duration of NIPPV/PPV or Vapotherm oxygen delivery | 7 days | ||
Secondary | Integrated FIO2 exposure | 7 days | ||
Secondary | Physician assessment - retractions, physician judgment of patient discomfort | 0, 2, 4 hrs |
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