Back to resultsHigh Flow Therapy for the Treatment of Respiratory Failure in the ED
Primary Purpose
Acute Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noninvasive positive pressure ventilation (NIPPV)
Vapotherm
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Respiratory Failure focused on measuring high flow therapy, high flow nasal cannula, acute respiratory failure, noninvasive ventilation
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
Sites / Locations
- Athens Regional Medical Center
- McLeod Regional Medical Center
- Erlanger Health System
- Memorial Hermann Hospital
- Memorial Hermann The Woodlands
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Noninvasive positive pressure ventilation
High flow therapy
Arm 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%.
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%.
Outcomes
Primary Outcome Measures
Treatment Failure Rate
Determine the efficacy of HFT compared to NIPPV in treating respiratory failure. The primary endpoint will be treatment failure within 72 hrs as determined by intubation.
Secondary Outcome Measures
Ventilatory Indices 1
Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventialtion (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia.
Ventilatory Indices 2
Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventilation (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Respiratory rate recorded at one and four hours, and at treatment failure if applicable.
Ventilatory Indices 3
Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventilation (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. SpO2 (a measurement of blood oxygen) recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).
Ventilatory Indices 4
Evaluate the capability of HFT, compared to NIPPV, to affect indices of ventilation. Patient discomfort as rated on a VAS recorded at one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).. NOTE: Due to need for patients to be alert and provide this rating, the number analyzed is less than the total patients in the trial.
VAS: Visual Analogue Scale. A Likert scale of facial expressions ranging from a smiley face to a frowning face used to assess the subjects' subjective level of dyspnea. Minimum 0 (no discomfort) to Maximum 5 (maximum discomfort).
Ventilatory Indices 5
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Modified Borg score recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable). NOTE: Due to the need for patients to be alert and able to provide this score, the number analyzed is less than the total patients in the trial.
A modified Borg scale was used to ask the patient to describe their effort on a scale of 0 to 10, where 10 is extreme discomfort.
Ventilatory Indices 6
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (pH), a measurement of CO2 levels, recorded at one and four hours, and at treatment failure if applicable.
NOTE: Due to test error, the number analyzed is less than the total patients in the trial.
Ventilatory Indices 7
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (PCO2), a measure of CO2, recorded at one and four hours, and at treatment failure if applicable.
NOTE: Due to test error, the number analyzed is less than the total patients in the trial.
Ventilatory Indices 8
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (HCO3), a meausre of blood oxygen/CO2 levels, recorded at one and four hours, and at treatment failure if applicable.
NOTE: Due to test error, the number analyzed is less than the total patients in the trial.
Ventilatory Indices 9
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (base excess), a measure of blood oxygen/CO2 levels, recorded at one and four hours, and at treatment failure if applicable.
NOTE: Due to test error, the number analyzed is less than the total patients in the trial.
Length of Stay
Evaluate the capability of HVNI, compared to NIPPV, to affect average length of stay.
Full Information
NCT ID
NCT02236559
First Posted
September 8, 2014
Last Updated
April 25, 2019
Sponsor
Vapotherm, Inc.
Collaborators
University of Texas, Memorial Hermann Texas Medical Center, Piedmont Athens Regional Medical Center, University of Tennessee, Erlanger Medical Center, Memorial Hermann The Woodlands, McLeod Regional Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02236559
Brief Title
High Flow Therapy for the Treatment of Respiratory Failure in the ED
Official Title
Vapotherm High Flow Therapy for the Treatment of Respiratory Failure in the ED: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vapotherm, Inc.
Collaborators
University of Texas, Memorial Hermann Texas Medical Center, Piedmont Athens Regional Medical Center, University of Tennessee, Erlanger Medical Center, Memorial Hermann The Woodlands, McLeod Regional Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
high flow therapy, high flow nasal cannula, acute respiratory failure, noninvasive ventilation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Noninvasive positive pressure ventilation
Arm Type
Active Comparator
Arm 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%.
Arm Title
High flow therapy
Arm Type
Experimental
Arm 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%.
Intervention Type
Device
Intervention Name(s)
Noninvasive positive pressure ventilation (NIPPV)
Other Intervention Name(s)
BIPAP
Intervention 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%.
Intervention Type
Device
Intervention Name(s)
Vapotherm
Other Intervention Name(s)
High flow nasal cannula
Intervention 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%.
Primary Outcome Measure Information:
Title
Treatment Failure Rate
Description
Determine the efficacy of HFT compared to NIPPV in treating respiratory failure. The primary endpoint will be treatment failure within 72 hrs as determined by intubation.
Time Frame
Within 72 hrs
Secondary Outcome Measure Information:
Title
Ventilatory Indices 1
Description
Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventialtion (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia.
Time Frame
At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).
Title
Ventilatory Indices 2
Description
Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventilation (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Respiratory rate recorded at one and four hours, and at treatment failure if applicable.
Time Frame
At baseline, 30 minutes, 60 minutes, 90 minutes, 4 hours, and treatment failure if applicable
Title
Ventilatory Indices 3
Description
Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventilation (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. SpO2 (a measurement of blood oxygen) recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).
Time Frame
At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).
Title
Ventilatory Indices 4
Description
Evaluate the capability of HFT, compared to NIPPV, to affect indices of ventilation. Patient discomfort as rated on a VAS recorded at one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).. NOTE: Due to need for patients to be alert and provide this rating, the number analyzed is less than the total patients in the trial.
VAS: Visual Analogue Scale. A Likert scale of facial expressions ranging from a smiley face to a frowning face used to assess the subjects' subjective level of dyspnea. Minimum 0 (no discomfort) to Maximum 5 (maximum discomfort).
Time Frame
At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).
Title
Ventilatory Indices 5
Description
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Modified Borg score recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable). NOTE: Due to the need for patients to be alert and able to provide this score, the number analyzed is less than the total patients in the trial.
A modified Borg scale was used to ask the patient to describe their effort on a scale of 0 to 10, where 10 is extreme discomfort.
Time Frame
at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable)
Title
Ventilatory Indices 6
Description
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (pH), a measurement of CO2 levels, recorded at one and four hours, and at treatment failure if applicable.
NOTE: Due to test error, the number analyzed is less than the total patients in the trial.
Time Frame
At one and four hours
Title
Ventilatory Indices 7
Description
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (PCO2), a measure of CO2, recorded at one and four hours, and at treatment failure if applicable.
NOTE: Due to test error, the number analyzed is less than the total patients in the trial.
Time Frame
At one and four hours
Title
Ventilatory Indices 8
Description
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (HCO3), a meausre of blood oxygen/CO2 levels, recorded at one and four hours, and at treatment failure if applicable.
NOTE: Due to test error, the number analyzed is less than the total patients in the trial.
Time Frame
At one and four hours
Title
Ventilatory Indices 9
Description
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (base excess), a measure of blood oxygen/CO2 levels, recorded at one and four hours, and at treatment failure if applicable.
NOTE: Due to test error, the number analyzed is less than the total patients in the trial.
Time Frame
At one and four hours
Title
Length of Stay
Description
Evaluate the capability of HVNI, compared to NIPPV, to affect average length of stay.
Time Frame
Duration of hospital visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pratik B Doshi, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas L Miller, PhD
Organizational Affiliation
Vapotherm, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Athens Regional Medical Center
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
McLeod Regional Medical Center
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29506
Country
United States
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Memorial Hermann The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29310868
Citation
Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.
Results Reference
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High Flow Therapy for the Treatment of Respiratory Failure in the ED
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