An interventional study of Noninvasive positive pressure ventilation (NIPPV) and Vapotherm in Acute Respiratory Failure, sponsored by Vapotherm, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-23.
Sponsored by Vapotherm, Inc. · Not applicable, Interventional, and Supportive care
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.
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Exclusion Criteria:
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 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 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%.
Also known as: BIPAP
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%.
Also known as: High flow nasal cannula
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.
Time frame: Within 72 hrs
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.
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).
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.
Time frame: At baseline, 30 minutes, 60 minutes, 90 minutes, 4 hours, and 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).
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).
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).
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).
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.
Time frame: at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable)
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.
Time frame: At one and four hours
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.
Time frame: At one and four hours
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.
Time frame: At one and four hours
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.
Time frame: At one and four hours
Length of Stay
Evaluate the capability of HVNI, compared to NIPPV, to affect average length of stay.
Time frame: Duration of hospital visit
| Milestone | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| Started | 112 | 116 |
| Completed | 100 | 104 |
| Not completed | 12 | 12 |
| Withdrew: Met exclusion | 3 | 6 |
| Withdrew: Did not meet inclusion | 3 | 3 |
| Withdrew: Subject did not consent | 4 | 2 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| Participants | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| Intubated at 72 Hours | 13 | 7 |
| Not Intubated at 72 hours | 87 | 97 |
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.
| beats per min | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| Heart Rate at Baseline | 101 ± 21.3 | 100.4 ± 21.2 |
| Heart Rate at 30 min | 96.4 ± 22 | 95.6 ± 20.4 |
| Heart Rate at 60 min | 93.7 ± 20.4 | 94 ± 18.4 |
| Heart Rate at 90 min | 92.2 ± 21.6 | 91.8 ± 17.8 |
| Heart Rate at 240 min | 89.6 ± 18.2 | 9.21 ± 17.4 |
| Heart Rate at Treatment Failure | 108.9 ± 33.5 | 106.4 ± 29.8 |
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.
| breaths per min | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| Respiratory Rate at Baseline | 29.3 ± 8.2 | 31.3 ± 8.2 |
| Respiratory Rate at 30 min | 25.6 ± 7.6 | 26.0 ± 6.1 |
| Respiratory Rate at 60 min | 23.4 ± 6.6 | 23.9 ± 5.5 |
| Respiratory Rate at 90 min | 22.7 ± 6.4 | 22.9 ± 5.8 |
| Respiratory Rate at 240 min | 22.1 ± 4.8 | 22.2 ± 4.7 |
| Respiratory Rate at Treatment Failure | 27.4 ± 10.2 | 26.4 ± 11.4 |
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).
| % SpO2 | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| SpO2 at Baseline | 93.5 ± 8.9 | 93.2 ± 7 |
| SpO2 at 30 min | 97.8 ± 3.3 | 97.5 ± 3.4 |
| SpO2 at 60 min | 97.8 ± 3 | 97.6 ± 3 |
| SpO2 at 90 min | 97.7 ± 2.3 | 97.8 ± 2.3 |
| SpO2 at 240 min | 96.8 ± 2.8 | 97.2 ± 2.3 |
| SpO2 at Treatment Failure | 91.4 ± 6.1 | 93.3 ± 3.8 |
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).
| score on a scale | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| VAS at Baseline | 4 ± .5 | 4 ± .5 |
| VAS at 30 min | 3 ± 0.5 | 3 ± 0.5 |
| VAS at 60 min | 2 ± .5 | 2 ± .5 |
| VAS at 90 min | 2 ± 0.5 | 2 ± 0.5 |
| VAS at 240 min | 2 ± .5 | 2 ± .4 |
| VAS at Treatment Failure | 4 ± 3.5 | 3 ± 2.5 |
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.
| score on a scale | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| Borg Score at Baseline | 6.5 ± 2.6 | 6.3 ± 3 |
| Borg Score at 30 min | 4.3 ± 2.7 | 4.3 ± 2.7 |
| Borg Score at 60 min | 3.3 ± 2.2 | 3.5 ± 2.2 |
| Borg Score at 90 min | 2.9 ± 2.2 | 3.3 ± 2.1 |
| Borg Score at 240 min | 2.2 ± 1.8 | 2.6 ± 2 |
| Borg Score at Treatment Failure | 7.1 ± 3 | 4.9 ± 3.5 |
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.
| pH | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| pH at Baseline | 7.33 ± .08 | 7.35 ± .1 |
| pH at 60 min | 7.34 ± .07 | 7.36 ± 0.08 |
| pH at 240 min | 7.36 ± .06 | 7.38 ± 0.07 |
| pH at Treatment Failure | 7.19 ± 0.04 | 7.25 ± 0.07 |
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.
| mmHg | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| PCO2 at Baseline | 58.7 ± 25 | 53.4 ± 20.6 |
| PCO2 at 60 min | 55.2 ± 21.5 | 52.0 ± 19.6 |
| PCO2 at 240 min | 52.5 ± 17.8 | 46.3 ± 12.7 |
| PCO2 at Treatment Failure | 66.2 ± 33.3 | 69.2 ± 32.1 |
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.
| mEq/L | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| HCO3 at Baseline | 29.8 ± 9.5 | 28.6 ± 8.6 |
| HCO3 at 60 min | 29.4 ± 9.5 | 28.4 ± 8.4 |
| HCO3 at 240 min | 29.3 ± 9.2 | 26.9 ± 6.1 |
| HCO3 at Treatment Failure | 26.5 ± 15.4 | 30.1 ± 13.7 |
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.
| mmol/L | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| Base excess at Baseline | 2.87 ± 7.76 | 2.35 ± 8.12 |
| Base excess at 60 min | 2.71 ± 7.92 | 2.3 ± 7.95 |
| Base excess at 240 min | 3.14 ± 7.79 | 1.47 ± 5.48 |
| Base excess at Treatment Failure | -2.12 ± 13.75 | 2.29 ± 12.88 |
Evaluate the capability of HVNI, compared to NIPPV, to affect average length of stay.
| days | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| Length of Stay | 6.0 ± 4.4 | 6.8 ± 5.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Noninvasive Positive Pressure Ventilation | — | 2/100 (2%) | 0/100 (0%) |
| High Velocity Nasal Insufflation | — | 0/104 (0%) | 0/104 (0%) |
| Event | Noninvasive Positive Pressure Ventilation | High Velocity Nasal Insufflation |
|---|---|---|
| Death Outside Study WindowCardiac disorders | 2/100 | 0/104 |
| Age, Continuous(years) | Noninvasive Positive Pressure Ventilation (NiPPV) | High Velocity Nasal Insufflation (HVNI) | Total |
|---|---|---|---|
| Mean | 63.3 ± 14.8 | 63.4 ± 13.6 | 63.3 ± 14.8 |
| Sex: Female, Male(Participants) | Noninvasive Positive Pressure Ventilation (NiPPV) | High Velocity Nasal Insufflation (HVNI) | Total |
|---|---|---|---|
| Female | 54 | 60 | 114 |
| Male | 46 | 44 | 90 |
| Race/Ethnicity, Customized(Participants) | Noninvasive Positive Pressure Ventilation (NiPPV) | High Velocity Nasal Insufflation (HVNI) | Total |
|---|---|---|---|
| American Indian | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| African | 33 | 28 | 61 |
| Latino | 8 | 8 | 16 |
| White | 57 | 67 | 124 |
| Other | 1 | 0 | 1 |
| Region of Enrollment(participants) | Noninvasive Positive Pressure Ventilation (NiPPV) | High Velocity Nasal Insufflation (HVNI) | Total |
|---|---|---|---|
| United States | 100 | 104 | 204 |
| Presenting Condition(Participants) | Noninvasive Positive Pressure Ventilation (NiPPV) | High Velocity Nasal Insufflation (HVNI) | Total |
|---|---|---|---|
| Asthma | 6 | 8 | 14 |
| Congestive Heart Failure | 14 | 19 | 33 |
| Chronic heart failure | 2 | 2 | 4 |
| Chronic Obstructive Pulmonary Disorder (COPD) | 41 | 38 | 79 |
| General dyspnea | 37 | 37 | 74 |
| Discharge Diagnosis(Participants) | Noninvasive Positive Pressure Ventilation (NiPPV) | High Velocity Nasal Insufflation (HVNI) | Total |
|---|---|---|---|
| Asthma | 3 | 4 | 7 |
| Acute decompensated heart failure | 20 | 22 | 42 |
| Acute COPD exacerbation | 24 | 29 | 53 |
| Acute hypercapnic respiratory failure | 7 | 5 | 12 |
| Acute hypoxic respiratory failure | 13 | 13 | 26 |
| Acute hypercapnic and hypoxic respiratory failure | 13 | 16 | 29 |
| Pneumonia/sepsis | 20 | 15 | 35 |
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Vapotherm, Inc.