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| Name | Class |
|---|---|
| University of Texas | OTHER |
| Memorial Hermann Texas Medical Center | UNKNOWN |
| Piedmont Athens Regional Medical Center | UNKNOWN |
| University of Tennessee |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noninvasive positive pressure ventilation | Active Comparator | 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%. |
|
| High flow therapy | Experimental | 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%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive positive pressure ventilation (NIPPV) | Device | 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 72 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pratik B Doshi, MD | University of Texas | Principal Investigator |
| Thomas L Miller, PhD | Vapotherm, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athens Regional Medical Center | Athens | Georgia | 30606 | United States | ||
| McLeod Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29310868 | Derived | 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. |
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24 patients randomized but not enrolled were excluded for meeting exclusion criteria (10), consent not obtained or withdrawn (6), bedside clinician not comfortable with enrollment after randomization (2), & patient identified to not need NiPPV after initial evaluation, thus failing to meet inclusion criteria (6). One patient met multiple criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Noninvasive Positive Pressure Ventilation | Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed. |
| FG001 | High Velocity Nasal Insufflation | High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort.The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Noninvasive positive-pressure ventilation (NiPPV). NiPPV(Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Within 72 hrs |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death Outside Study Window | Cardiac disorders | Non-systematic Assessment | Cardiac arrest leading to death prior to discharge but outside the study window. Determined by the principal investigator to not be study related. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pratik Doshi, MD | McGovern Medical School at The University of Texas Health Science Center at Houston | pratik.b.doshi@uth.tmc.edu |
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| OTHER |
| Erlanger Medical Center | UNKNOWN |
| Memorial Hermann The Woodlands | UNKNOWN |
| McLeod Regional Medical Center | UNKNOWN |
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|
|
| Vapotherm | Device | 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%. |
|
|
| 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. | 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). | 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). | 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. | 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. | 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. | 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. | 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. | At one and four hours |
| Length of Stay | Evaluate the capability of HVNI, compared to NIPPV, to affect average length of stay. | Duration of hospital visit |
| Florence |
| South Carolina |
| 29506 |
| United States |
| Erlanger Health System | Chattanooga | Tennessee | 37403 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Memorial Hermann The Woodlands | The Woodlands | Texas | 77380 | United States |
| Subject Did Not Consent |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| BG001 | High Velocity Nasal Insufflation (HVNI) | 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 High Velocity Nasal Insufflation (HVNI). HVNI (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Presenting Condition | Count of Participants | Participants |
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| Discharge Diagnosis | Count of Participants | Participants |
|
| OG001 | High Velocity Nasal Insufflation | 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. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed. |
|
|
| Secondary | 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. | If treatment failed prior to followup recording, subsequent data was not collected per the protocol. | Posted | Mean | Standard Deviation | beats per min | 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). |
|
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| Secondary | 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. | If treatment failed prior to followup recording, subsequent data was not collected per the protocol. | Posted | Mean | Standard Deviation | breaths per min | At baseline, 30 minutes, 60 minutes, 90 minutes, 4 hours, and treatment failure if applicable |
|
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| Secondary | 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). | If treatment failed prior to followup recording, subsequent data was not collected per the protocol. | Posted | Mean | Standard Deviation | % SpO2 | 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). |
|
|
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| Secondary | 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). | If treatment failed prior to followup recording, subsequent data was not collected per the protocol. Some participants were unable to give scores due to health status. | Posted | Mean | Standard Deviation | score on a scale | 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). |
|
|
|
| Secondary | 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. | If treatment failed prior to followup recording, subsequent data was not collected per the protocol. Some participants were unable to give scores due to health status. | Posted | Mean | Standard Deviation | score on a scale | at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable) |
|
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| Secondary | 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. | If treatment failed prior to followup recording, subsequent data was not collected per the protocol. | Posted | Mean | Standard Deviation | pH | At one and four hours |
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| Secondary | 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. | If treatment failed prior to followup recording, subsequent data was not collected per the protocol. | Posted | Mean | Standard Deviation | mmHg | At one and four hours |
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| Secondary | 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. | If treatment failed prior to followup recording, subsequent data was not collected per the protocol. | Posted | Mean | Standard Deviation | mEq/L | At one and four hours |
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| Secondary | 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. | If treatment failed prior to followup recording, subsequent data was not collected per the protocol. | Posted | Mean | Standard Deviation | mmol/L | At one and four hours |
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| Secondary | Length of Stay | Evaluate the capability of HVNI, compared to NIPPV, to affect average length of stay. | Posted | Mean | Standard Deviation | days | Duration of hospital visit |
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| 2 |
| 100 |
| 0 |
| 100 |
| EG001 | High Velocity Nasal Insufflation | 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. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed. | 0 | 104 | 0 | 104 |
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| Heart Rate at 30 min |
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| Heart Rate at 60 min |
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| Heart Rate at 90 min |
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| Heart Rate at 240 min |
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| Heart Rate at Treatment Failure |
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| Respiratory Rate at 60 min |
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| Respiratory Rate at 90 min |
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| Respiratory Rate at 240 min |
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| Respiratory Rate at Treatment Failure |
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| SpO2 at 30 min |
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| SpO2 at 60 min |
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| SpO2 at 90 min |
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| SpO2 at 240 min |
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| SpO2 at Treatment Failure |
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| VAS at 30 min |
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| VAS at 90 min |
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| Borg Score at 90 min |
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| Borg Score at 240 min |
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| Borg Score at Treatment Failure |
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| pH at 60 min |
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| pH at 240 min |
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| pH at Treatment Failure |
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| PCO2 at 60 min |
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| PCO2 at 240 min |
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| PCO2 at Treatment Failure |
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| HCO3 at 60 min |
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| HCO3 at 240 min |
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| HCO3 at Treatment Failure |
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| Base excess at 60 min |
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| Base excess at 240 min |
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| Base excess at Treatment Failure |
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