N/A N=228 Randomized Supportive Care

High Flow Therapy for the Treatment of Respiratory Failure in the ED

Acute Respiratory Failure

Bottom Line

View on ClinicalTrials.gov: NCT02236559 ↗

Enrolled (actual)

228

Serious AEs

1.0%

Results posted

May 2019

Primary outcome: Primary: Treatment Failure Rate — 13; 7; 87; 97 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Noninvasive positive pressure ventilation (NIPPV) (Device); Vapotherm (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vapotherm, Inc.
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Failure Rate	13; 7; 87; 97	—
SECONDARY Ventilatory Indices 1	101; 100.4; 96.4; 95.6; 93.7; 94	—
SECONDARY Ventilatory Indices 2	29.3; 31.3; 25.6; 26.0; 23.4; 23.9	—
SECONDARY Ventilatory Indices 3	93.5; 93.2; 97.8; 97.5; 97.8; 97.6	—
SECONDARY Ventilatory Indices 4	4; 4; 3; 3; 2; 2	—
SECONDARY Ventilatory Indices 5	6.5; 6.3; 4.3; 4.3; 3.3; 3.5	—
SECONDARY Ventilatory Indices 6	7.33; 7.35; 7.34; 7.36; 7.36; 7.38	—
SECONDARY Ventilatory Indices 7	58.7; 53.4; 55.2; 52.0; 52.5; 46.3	—
SECONDARY Ventilatory Indices 8	29.8; 28.6; 29.4; 28.4; 29.3; 26.9	—
SECONDARY Ventilatory Indices 9	2.87; 2.35; 2.71; 2.3; 3.14; 1.47	—
SECONDARY Length of Stay	6.0; 6.8	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02236559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.