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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Athens Regional Medical Center
Athens, Georgia, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Erlanger Health System
Chattanooga, Tennessee, United States
Memorial Hermann Hospital
Houston, Texas, United States
Memorial Hermann The Woodlands
The Woodlands, Texas, United States
Start Date
September 1, 2014
Primary Completion Date
September 1, 2016
Completion Date
February 1, 2017
Last Updated
May 23, 2019
204
ACTUAL participants
Noninvasive positive pressure ventilation (NIPPV)
DEVICE
Vapotherm
DEVICE
Lead Sponsor
Vapotherm, Inc.
Collaborators
NCT05423301
NCT06750536
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06934876