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| ID | Type | Description | Link |
|---|---|---|---|
| Temple IRB protocol # 12573 |
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Pilot enrollment criteria did not yield intended population.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High FLow Therapy | Experimental | Use of High Flow Therapy for support of Respiratory Insufficiency |
|
| NiPPV | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vapotherm High Flow Therapy | Device | use of high flow nasal cannula to support oxygenation and CO2 removal by flushing the nasopharynx with warmed, humidified respiratory gas at flow rates that exceed a patient's inspiratory flow rate |
| Measure | Description | Time Frame |
|---|---|---|
| Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV) | While in Emergency Department; at 24 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Borg Dyspnea Scale | 0, 2, 4 hrs | |
| Respiratory Rate | 0, 2, 4 hrs | |
| Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE- |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marla R Wolfson, PhD | Temple University | Principal Investigator |
| Nina Gentile, MD | Temple University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19467849 | Background | 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. |
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| Non-invasive positive pressure ventilation | Device | Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV. Initial pressures will be at low end of suggested range but can be increased as rapidly as necessary to alleviate respiratory distress. |
|
| 0, 2, 4 hrs |
| Pulse Ox and FIO2 | 0, 2, 4 hrs |
| Intensive Care Unit admission rate / Length of Stay | 7 days |
| Hospital Length of Stay | 7 days |
| Total duration of NIPPV/PPV or Vapotherm oxygen delivery | 7 days |
| Integrated FIO2 exposure | 7 days |
| Physician assessment - retractions, physician judgment of patient discomfort | 0, 2, 4 hrs |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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