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

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ClinicalTrials.gov Identifier: NCT02236559
Recruitment Status : Completed
First Posted : September 10, 2014
Results First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
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
Information provided by (Responsible Party):
Vapotherm, Inc.

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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Device: Noninvasive positive pressure ventilation (NIPPV) Device: Vapotherm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Vapotherm High Flow Therapy for the Treatment of Respiratory Failure in the ED: A Randomized Controlled Trial
Study Start Date : September 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Noninvasive positive pressure ventilation

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: 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%.

Other Name: BIPAP

Experimental: High flow therapy

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%.

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%.
Other Name: High flow nasal cannula




Primary Outcome Measures :
  1. Treatment Failure Rate [ Time Frame: Within 72 hrs ]
    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 :
  1. Ventilatory Indices 1 [ 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). ]
    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.

  2. Ventilatory Indices 2 [ Time Frame: At baseline, 30 minutes, 60 minutes, 90 minutes, 4 hours, and treatment failure if applicable ]
    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.

  3. Ventilatory Indices 3 [ 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). ]
    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).

  4. Ventilatory Indices 4 [ 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). ]

    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).


  5. Ventilatory Indices 5 [ Time Frame: at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable) ]

    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.


  6. Ventilatory Indices 6 [ Time Frame: At one and four hours ]

    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.


  7. Ventilatory Indices 7 [ Time Frame: At one and four hours ]

    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.


  8. Ventilatory Indices 8 [ Time Frame: At one and four hours ]

    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.


  9. Ventilatory Indices 9 [ Time Frame: At one and four hours ]

    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.


  10. Length of Stay [ Time Frame: Duration of hospital visit ]
    Evaluate the capability of HVNI, compared to NIPPV, to affect average length of stay.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236559


Locations
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United States, Georgia
Athens Regional Medical Center
Athens, Georgia, United States, 30606
United States, South Carolina
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
United States, Tennessee
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Memorial Hermann The Woodlands
The Woodlands, Texas, United States, 77380
Sponsors and Collaborators
Vapotherm, Inc.
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
Investigators
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Principal Investigator: Pratik B Doshi, MD University of Texas
Study Director: Thomas L Miller, PhD Vapotherm, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vapotherm, Inc.
ClinicalTrials.gov Identifier: NCT02236559    
Other Study ID Numbers: RP-EDPF2014001Dev
First Posted: September 10, 2014    Key Record Dates
Results First Posted: May 23, 2019
Last Update Posted: May 23, 2019
Last Verified: April 2019
Keywords provided by Vapotherm, Inc.:
high flow therapy
high flow nasal cannula
acute respiratory failure
noninvasive ventilation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases