N/A
Completed N=228
High Flow Therapy for the Treatment of Respiratory Failure in the ED
Source: ClinicalTrials.gov NCT02236559 ↗Enrolled (actual)
228
Serious AEs
1.0%
Results posted
May 2019
Primary outcomePrimary: Treatment Failure Rate — 13; 7; 87; 97 Participants
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.
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 | — |
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
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. Informational only — not medical advice.