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

Vapotherm

Status: Completed

Conditions: Acute Respiratory Failure

Treatments: Device: Vapotherm; Device: Noninvasive positive pressure ventilation (NIPPV)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02236559

RP-EDPF2014001Dev

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Noninvasive positive pressure ventilation

Active Comparator group

Description:

Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV. Initial pressures will be at low end of suggested range but can be increased as rapidly as necessary to alleviate respiratory distress. Targets should be to lower respiratory rate to the low 20s and achieve tidal volumes of 6-8 ml/kg ideal body weight. If patients find pressures uncomfortably high, they can be lowered as necessary by 1 to 2 cmH2O decrements to enhance tolerance. EPAP (PEEP) can also be adjusted upward as needed to reduce triggering effort (by counterbalancing auto-PEEP) or to improve oxygenation. FIO2 will be 1.0 initially to assure adequate oxygenation, but should be adjusted promptly to maintain an FIO2 of no greater than 0.6 with an EPAP (PEEP) of not more than 10 cm H2O to maintain a PaO2 \> 88%.

Treatment:

Device: Noninvasive positive pressure ventilation (NIPPV)

High flow therapy

Experimental group

Description:

Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. Initial flow will be set to 35 L/min but can be decreased or increased as rapidly as necessary to alleviate respiratory distress and optimize patient comfort. Targets should be to lower respiratory rate to the low 20s and with a HFT flow rate between 20 to 35 L/min. Starting temperature will be between 35 to 37 C; if patients find the gas temperature to be uncomfortable, it can be lowered as necessary down to 33 C to enhance tolerance. FIO2 will be 1.0 initially to assure adequate oxygenation, but should be adjusted promptly to maintain an FIO2 of no greater than 0.6 to maintain a PaO2 \> 88%.

Treatment:

Device: Vapotherm