Status:
COMPLETED
High Flow Therapy for the Treatment of Respiratory Failure in the ED
Lead Sponsor:
Vapotherm, Inc.
Collaborating Sponsors:
University of Texas
Memorial Hermann Texas Medical Center
Conditions:
Acute Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The overall objective of this study is to determine if Vapotherm high flow nasal cannula therapy (HFT), when used to treat respiratory failure in the ED, is at least equivalent to the current standard...
Eligibility Criteria
Inclusion
- Adult patients (\> 18 yrs of age)
- Presentation with acute respiratory failure according to the following criteria:
- If any of these are present: Respiratory Rate \>22 or labored; Suspected Acute Respiratory Acidosis, as defined as pH \<7.32 on initial blood gas(either arterial or venous); Hypoxemia, as defined as Pulse Ox \<92%;
- Clinical decision to escalate therapy to non-invasive ventilatory support, or to maintain non-invasive ventilatory support if delivered to the ED on such.
Exclusion
- Suspected drug overdose
- Cardiovascular instability as demonstrated by hypotension relative to initial clinical presentation that requires immediate intervention
- End stage cancer
- Life expectancy \< 6 months
- Respiratory arrest or significant respiratory depression on presentation
- Glasgow Coma Scale score \< 9
- Cardiac arrest on initial presentation
- Need for emergent intubation
- Known or suspected cerebrovascular accident
- Known or suspected ST segment elevation myocardial infarction
- Patients with increased risk of pulmonary aspiration
- Agitation or uncooperativeness
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT02236559
Start Date
September 1 2014
End Date
February 1 2017
Last Update
May 23 2019
Active Locations (5)
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1
Athens Regional Medical Center
Athens, Georgia, United States, 30606
2
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
3
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
4
Memorial Hermann Hospital
Houston, Texas, United States, 77030