High Flow Therapy for the Treatment of Respiratory Failure in the ED
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | December 2016 |
| Contact: | Pratik B Doshi, MD |
| Email: | pratik.b.doshi@uth.tmc.edu |
| Phone: | 832-314-8062 |
Vapotherm High Flow Therapy for the Treatment of Respiratory Failure in the ED: A Randomized Controlled Trial
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 of care for non-invasive ventilatory support, non-invasive positive
pressure mask ventilation (NIPPV). Moreover, this study will investigate the potential that
HFT has possible advantages over NIPPV, such as decreased time to patient stability from
respiratory failure, and the ease of use as a first line intervention for respiratory
failure in the ED environment.
The hypothesis is that HFT via the Vapotherm Precision Flow will demonstrate clinical
non-inferiority when compared to NIPPV with regard to treatment failure by way of an impact
on ventilation indices and a lower intolerance rate, and have a positive association with
hospital disposition and length of stay.
therapy (HFT), when used to treat respiratory failure in the ED, is at least equivalent to
the current standard of care for non-invasive ventilatory support, non-invasive positive
pressure mask ventilation (NIPPV). Moreover, this study will investigate the potential that
HFT has possible advantages over NIPPV, such as decreased time to patient stability from
respiratory failure, and the ease of use as a first line intervention for respiratory
failure in the ED environment.
The hypothesis is that HFT via the Vapotherm Precision Flow will demonstrate clinical
non-inferiority when compared to NIPPV with regard to treatment failure by way of an impact
on ventilation indices and a lower intolerance rate, and have a positive association with
hospital disposition and length of stay.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
3
sites
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Houston, Texas 77030
Principal Investigator: Pratik B Doshi, MD
Phone: 832-314-8062
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