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

NACompletedINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

September 30, 2016

Study Completion Date

February 28, 2017

Conditions
Acute Respiratory Failure
Interventions
DEVICE

Noninvasive positive pressure ventilation (NIPPV)

"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%."

DEVICE

Vapotherm

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%.

Trial Locations (5)

29506

McLeod Regional Medical Center, Florence

30606

Athens Regional Medical Center, Athens

37403

Erlanger Health System, Chattanooga

77030

Memorial Hermann Hospital, Houston

77380

Memorial Hermann The Woodlands, The Woodlands

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Texas

OTHER

collaborator

Memorial Hermann Texas Medical Center

UNKNOWN

collaborator

Piedmont Athens Regional Medical Center

UNKNOWN

collaborator

University of Tennessee

OTHER

collaborator

Erlanger Medical Center

UNKNOWN

collaborator

Memorial Hermann The Woodlands

UNKNOWN

collaborator

McLeod Regional Medical Center

UNKNOWN

lead

Vapotherm, Inc.

INDUSTRY