Clinical trial NCT02236559: High Flow Therapy for the Treatment of Respiratory Failure in the ED
Official title: Vapotherm High Flow Therapy for the Treatment of Respiratory Failure in the ED: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: high flow therapy
high flow nasal cannula
acute respiratory failure
noninvasive ventilation
Lead sponsor: Vapotherm, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Texas
name: Memorial Hermann Texas Medical Center
name: Piedmont Athens Regional Medical Center
name: University of Tennessee
name: Erlanger Medical Center
name: Memorial Hermann The Woodlands
name: McLeod Regional Medical Center
First posted: 2014-09-10
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment Failure Rate
timeFrame: Within 72 hrs
Secondary outcomes:
measure: Ventilatory Indices 1
timeFrame: At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).
measure: Ventilatory Indices 2
timeFrame: At baseline, 30 minutes, 60 minutes, 90 minutes, 4 hours, and treatment failure if applicable
measure: Ventilatory Indices 3
timeFrame: At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).
measure: Ventilatory Indices 4
timeFrame: At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).
measure: Ventilatory Indices 5
timeFrame: at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable)
measure: Ventilatory Indices 6
timeFrame: At one and four hours
measure: Ventilatory Indices 7
timeFrame: At one and four hours
measure: Ventilatory Indices 8
timeFrame: At one and four hours
measure: Ventilatory Indices 9
timeFrame: At one and four hours
measure: Length of Stay
timeFrame: Duration of hospital visit
Other outcomes:
Locations:
city: Athens
country: United States
facility: Athens Regional Medical Center
state: Georgia
city: Florence
country: United States
facility: McLeod Regional Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: The Woodlands
country: United States
facility: Memorial Hermann The Woodlands
state: Texas
Study officials:
affiliation: University of Texas
name: Pratik B Doshi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vapotherm, Inc.
name: Thomas L Miller, PhD
role: STUDY_DIRECTOR
References:
citation: Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.