204
Participants
Start Date
September 30, 2014
Primary Completion Date
September 30, 2016
Study Completion Date
February 28, 2017
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%."
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%.
McLeod Regional Medical Center, Florence
Athens Regional Medical Center, Athens
Erlanger Health System, Chattanooga
Memorial Hermann Hospital, Houston
Memorial Hermann The Woodlands, The Woodlands
Collaborators (1)
University of Texas
OTHER
Memorial Hermann Texas Medical Center
UNKNOWN
Piedmont Athens Regional Medical Center
UNKNOWN
University of Tennessee
OTHER
Erlanger Medical Center
UNKNOWN
Memorial Hermann The Woodlands
UNKNOWN
McLeod Regional Medical Center
UNKNOWN
Vapotherm, Inc.
INDUSTRY