Vapotherm High Flow Therapy Via Nasal Cannula to Treat Respiratory Insufficiency in Patients With Chronic Obstructive Pulmonary Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Vapotherm, Inc.
- Locations
- 2
- Primary Endpoint
- Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Radiographic evidence of pneumonia
- •Glasgow Coma score < 14 or unable to correctly answer at least one study-specific question
Outcomes
Primary Outcomes
Institution of positive pressure ventilation (PPV) or non-invasive positive pressure ventilation (NIPPV)
Time Frame: While in Emergency Department; at 24 hrs
Secondary Outcomes
- Pulse Ox and FIO2(0, 2, 4 hrs)
- Arterial blood chemistry including pH, pCO2, pO2, HCO3-, BE-(0, 2, 4 hrs)
- Hospital Length of Stay(7 days)
- Intensive Care Unit admission rate / Length of Stay(7 days)
- Borg Dyspnea Scale(0, 2, 4 hrs)
- Respiratory Rate(0, 2, 4 hrs)
- Total duration of NIPPV/PPV or Vapotherm oxygen delivery(7 days)
- Physician assessment - retractions, physician judgment of patient discomfort(0, 2, 4 hrs)
- Integrated FIO2 exposure(7 days)