Acute Respiratory Failure
Conditions
Keywords
high flow therapy, high flow nasal cannula, acute respiratory failure, noninvasive ventilation
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.
Interventions
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%.
DEVICEVapotherm
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%.
Sponsors
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
Vapotherm, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failure Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Ventilatory Indices 2 | 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. |
| Ventilatory Indices 3 | 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). |
| Ventilatory Indices 4 | 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). |
| Ventilatory Indices 5 | 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. |
| Ventilatory Indices 1 | 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. |
| Ventilatory Indices 7 | 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. |
| Ventilatory Indices 8 | 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. |
| Ventilatory Indices 9 | 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. |
| Length of Stay | Duration of hospital visit | Evaluate the capability of HVNI, compared to NIPPV, to affect average length of stay. |
| Ventilatory Indices 6 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| 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. | 104 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not Meet Inclusion | 3 | 3 |
| Overall Study | Met Exclusion | 3 | 6 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Subject Did Not Consent | 4 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Noninvasive Positive Pressure Ventilation (NiPPV) | High Velocity Nasal Insufflation (HVNI) | Total |
|---|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 14.8 | 63.4 years STANDARD_DEVIATION 13.6 | 63.3 years STANDARD_DEVIATION 14.8 |
| Discharge Diagnosis Acute COPD exacerbation | 24 Participants | 29 Participants | 53 Participants |
| Discharge Diagnosis Acute decompensated heart failure | 20 Participants | 22 Participants | 42 Participants |
| Discharge Diagnosis Acute hypercapnic and hypoxic respiratory failure | 13 Participants | 16 Participants | 29 Participants |
| Discharge Diagnosis Acute hypercapnic respiratory failure | 7 Participants | 5 Participants | 12 Participants |
| Discharge Diagnosis Acute hypoxic respiratory failure | 13 Participants | 13 Participants | 26 Participants |
| Discharge Diagnosis Asthma | 3 Participants | 4 Participants | 7 Participants |
| Discharge Diagnosis Pneumonia/sepsis | 20 Participants | 15 Participants | 35 Participants |
| Presenting Condition Asthma | 6 Participants | 8 Participants | 14 Participants |
| Presenting Condition Chronic heart failure | 2 Participants | 2 Participants | 4 Participants |
| Presenting Condition Chronic Obstructive Pulmonary Disorder (COPD) | 41 Participants | 38 Participants | 79 Participants |
| Presenting Condition Congestive Heart Failure | 14 Participants | 19 Participants | 33 Participants |
| Presenting Condition General dyspnea | 37 Participants | 37 Participants | 74 Participants |
| Race/Ethnicity, Customized African | 33 Participants | 28 Participants | 61 Participants |
| Race/Ethnicity, Customized American Indian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Latino | 8 Participants | 8 Participants | 16 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 57 Participants | 67 Participants | 124 Participants |
| Region of Enrollment United States | 100 participants | 104 participants | 204 participants |
| Sex: Female, Male Female | 54 Participants | 60 Participants | 114 Participants |
| Sex: Female, Male Male | 46 Participants | 44 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 104 |
| serious Total, serious adverse events | 2 / 100 | 0 / 104 |
Outcome results
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.
Time frame: Within 72 hrs
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Noninvasive Positive Pressure Ventilation | Treatment Failure Rate | Intubated at 72 Hours | 13 Participants |
| Noninvasive Positive Pressure Ventilation | Treatment Failure Rate | Not Intubated at 72 hours | 87 Participants |
| High Velocity Nasal Insufflation | Treatment Failure Rate | Intubated at 72 Hours | 7 Participants |
| High Velocity Nasal Insufflation | Treatment Failure Rate | Not Intubated at 72 hours | 97 Participants |
Secondary
Length of Stay
Evaluate the capability of HVNI, compared to NIPPV, to affect average length of stay.
Time frame: Duration of hospital visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Noninvasive Positive Pressure Ventilation | Length of Stay | 6.0 days | Standard Deviation 4.4 |
| High Velocity Nasal Insufflation | Length of Stay | 6.8 days | Standard Deviation 5.7 |
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.
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).
Population: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 1 | Heart Rate at Baseline | 101 beats per min | Standard Deviation 21.3 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 1 | Heart Rate at 30 min | 96.4 beats per min | Standard Deviation 22 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 1 | Heart Rate at 60 min | 93.7 beats per min | Standard Deviation 20.4 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 1 | Heart Rate at 90 min | 92.2 beats per min | Standard Deviation 21.6 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 1 | Heart Rate at 240 min | 89.6 beats per min | Standard Deviation 18.2 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 1 | Heart Rate at Treatment Failure | 108.9 beats per min | Standard Deviation 33.5 |
| High Velocity Nasal Insufflation | Ventilatory Indices 1 | Heart Rate at 240 min | 9.21 beats per min | Standard Deviation 17.4 |
| High Velocity Nasal Insufflation | Ventilatory Indices 1 | Heart Rate at Baseline | 100.4 beats per min | Standard Deviation 21.2 |
| High Velocity Nasal Insufflation | Ventilatory Indices 1 | Heart Rate at 90 min | 91.8 beats per min | Standard Deviation 17.8 |
| High Velocity Nasal Insufflation | Ventilatory Indices 1 | Heart Rate at 30 min | 95.6 beats per min | Standard Deviation 20.4 |
| High Velocity Nasal Insufflation | Ventilatory Indices 1 | Heart Rate at Treatment Failure | 106.4 beats per min | Standard Deviation 29.8 |
| High Velocity Nasal Insufflation | Ventilatory Indices 1 | Heart Rate at 60 min | 94 beats per min | Standard Deviation 18.4 |
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.
Time frame: At baseline, 30 minutes, 60 minutes, 90 minutes, 4 hours, and treatment failure if applicable
Population: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 2 | Respiratory Rate at Baseline | 29.3 breaths per min | Standard Deviation 8.2 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 2 | Respiratory Rate at 30 min | 25.6 breaths per min | Standard Deviation 7.6 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 2 | Respiratory Rate at 60 min | 23.4 breaths per min | Standard Deviation 6.6 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 2 | Respiratory Rate at 90 min | 22.7 breaths per min | Standard Deviation 6.4 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 2 | Respiratory Rate at 240 min | 22.1 breaths per min | Standard Deviation 4.8 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 2 | Respiratory Rate at Treatment Failure | 27.4 breaths per min | Standard Deviation 10.2 |
| High Velocity Nasal Insufflation | Ventilatory Indices 2 | Respiratory Rate at 240 min | 22.2 breaths per min | Standard Deviation 4.7 |
| High Velocity Nasal Insufflation | Ventilatory Indices 2 | Respiratory Rate at Baseline | 31.3 breaths per min | Standard Deviation 8.2 |
| High Velocity Nasal Insufflation | Ventilatory Indices 2 | Respiratory Rate at 90 min | 22.9 breaths per min | Standard Deviation 5.8 |
| High Velocity Nasal Insufflation | Ventilatory Indices 2 | Respiratory Rate at 30 min | 26.0 breaths per min | Standard Deviation 6.1 |
| High Velocity Nasal Insufflation | Ventilatory Indices 2 | Respiratory Rate at Treatment Failure | 26.4 breaths per min | Standard Deviation 11.4 |
| High Velocity Nasal Insufflation | Ventilatory Indices 2 | Respiratory Rate at 60 min | 23.9 breaths per min | Standard Deviation 5.5 |
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).
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).
Population: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 3 | SpO2 at Baseline | 93.5 % SpO2 | Standard Deviation 8.9 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 3 | SpO2 at 30 min | 97.8 % SpO2 | Standard Deviation 3.3 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 3 | SpO2 at 60 min | 97.8 % SpO2 | Standard Deviation 3 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 3 | SpO2 at 90 min | 97.7 % SpO2 | Standard Deviation 2.3 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 3 | SpO2 at 240 min | 96.8 % SpO2 | Standard Deviation 2.8 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 3 | SpO2 at Treatment Failure | 91.4 % SpO2 | Standard Deviation 6.1 |
| High Velocity Nasal Insufflation | Ventilatory Indices 3 | SpO2 at 240 min | 97.2 % SpO2 | Standard Deviation 2.3 |
| High Velocity Nasal Insufflation | Ventilatory Indices 3 | SpO2 at Baseline | 93.2 % SpO2 | Standard Deviation 7 |
| High Velocity Nasal Insufflation | Ventilatory Indices 3 | SpO2 at 90 min | 97.8 % SpO2 | Standard Deviation 2.3 |
| High Velocity Nasal Insufflation | Ventilatory Indices 3 | SpO2 at 30 min | 97.5 % SpO2 | Standard Deviation 3.4 |
| High Velocity Nasal Insufflation | Ventilatory Indices 3 | SpO2 at Treatment Failure | 93.3 % SpO2 | Standard Deviation 3.8 |
| High Velocity Nasal Insufflation | Ventilatory Indices 3 | SpO2 at 60 min | 97.6 % SpO2 | Standard Deviation 3 |
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).
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).
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 4 | VAS at Baseline | 4 score on a scale | Standard Deviation 0.5 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 4 | VAS at 30 min | 3 score on a scale | Standard Deviation 0.5 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 4 | VAS at 60 min | 2 score on a scale | Standard Deviation 0.5 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 4 | VAS at 90 min | 2 score on a scale | Standard Deviation 0.5 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 4 | VAS at 240 min | 2 score on a scale | Standard Deviation 0.5 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 4 | VAS at Treatment Failure | 4 score on a scale | Standard Deviation 3.5 |
| High Velocity Nasal Insufflation | Ventilatory Indices 4 | VAS at 240 min | 2 score on a scale | Standard Deviation 0.4 |
| High Velocity Nasal Insufflation | Ventilatory Indices 4 | VAS at Baseline | 4 score on a scale | Standard Deviation 0.5 |
| High Velocity Nasal Insufflation | Ventilatory Indices 4 | VAS at 90 min | 2 score on a scale | Standard Deviation 0.5 |
| High Velocity Nasal Insufflation | Ventilatory Indices 4 | VAS at 30 min | 3 score on a scale | Standard Deviation 0.5 |
| High Velocity Nasal Insufflation | Ventilatory Indices 4 | VAS at Treatment Failure | 3 score on a scale | Standard Deviation 2.5 |
| High Velocity Nasal Insufflation | Ventilatory Indices 4 | VAS at 60 min | 2 score on a scale | Standard Deviation 0.5 |
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.
Time frame: at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 5 | Borg Score at Baseline | 6.5 score on a scale | Standard Deviation 2.6 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 5 | Borg Score at 30 min | 4.3 score on a scale | Standard Deviation 2.7 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 5 | Borg Score at 60 min | 3.3 score on a scale | Standard Deviation 2.2 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 5 | Borg Score at 90 min | 2.9 score on a scale | Standard Deviation 2.2 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 5 | Borg Score at 240 min | 2.2 score on a scale | Standard Deviation 1.8 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 5 | Borg Score at Treatment Failure | 7.1 score on a scale | Standard Deviation 3 |
| High Velocity Nasal Insufflation | Ventilatory Indices 5 | Borg Score at 240 min | 2.6 score on a scale | Standard Deviation 2 |
| High Velocity Nasal Insufflation | Ventilatory Indices 5 | Borg Score at Baseline | 6.3 score on a scale | Standard Deviation 3 |
| High Velocity Nasal Insufflation | Ventilatory Indices 5 | Borg Score at 90 min | 3.3 score on a scale | Standard Deviation 2.1 |
| High Velocity Nasal Insufflation | Ventilatory Indices 5 | Borg Score at 30 min | 4.3 score on a scale | Standard Deviation 2.7 |
| High Velocity Nasal Insufflation | Ventilatory Indices 5 | Borg Score at Treatment Failure | 4.9 score on a scale | Standard Deviation 3.5 |
| High Velocity Nasal Insufflation | Ventilatory Indices 5 | Borg Score at 60 min | 3.5 score on a scale | Standard Deviation 2.2 |
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.
Time frame: At one and four hours
Population: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 6 | pH at Baseline | 7.33 pH | Standard Deviation 0.08 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 6 | pH at 60 min | 7.34 pH | Standard Deviation 0.07 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 6 | pH at 240 min | 7.36 pH | Standard Deviation 0.06 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 6 | pH at Treatment Failure | 7.19 pH | Standard Deviation 0.04 |
| High Velocity Nasal Insufflation | Ventilatory Indices 6 | pH at Treatment Failure | 7.25 pH | Standard Deviation 0.07 |
| High Velocity Nasal Insufflation | Ventilatory Indices 6 | pH at Baseline | 7.35 pH | Standard Deviation 0.1 |
| High Velocity Nasal Insufflation | Ventilatory Indices 6 | pH at 240 min | 7.38 pH | Standard Deviation 0.07 |
| High Velocity Nasal Insufflation | Ventilatory Indices 6 | pH at 60 min | 7.36 pH | Standard Deviation 0.08 |
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.
Time frame: At one and four hours
Population: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 7 | PCO2 at Baseline | 58.7 mmHg | Standard Deviation 25 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 7 | PCO2 at 60 min | 55.2 mmHg | Standard Deviation 21.5 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 7 | PCO2 at 240 min | 52.5 mmHg | Standard Deviation 17.8 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 7 | PCO2 at Treatment Failure | 66.2 mmHg | Standard Deviation 33.3 |
| High Velocity Nasal Insufflation | Ventilatory Indices 7 | PCO2 at Treatment Failure | 69.2 mmHg | Standard Deviation 32.1 |
| High Velocity Nasal Insufflation | Ventilatory Indices 7 | PCO2 at Baseline | 53.4 mmHg | Standard Deviation 20.6 |
| High Velocity Nasal Insufflation | Ventilatory Indices 7 | PCO2 at 240 min | 46.3 mmHg | Standard Deviation 12.7 |
| High Velocity Nasal Insufflation | Ventilatory Indices 7 | PCO2 at 60 min | 52.0 mmHg | Standard Deviation 19.6 |
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.
Time frame: At one and four hours
Population: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 8 | HCO3 at Baseline | 29.8 mEq/L | Standard Deviation 9.5 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 8 | HCO3 at 60 min | 29.4 mEq/L | Standard Deviation 9.5 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 8 | HCO3 at 240 min | 29.3 mEq/L | Standard Deviation 9.2 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 8 | HCO3 at Treatment Failure | 26.5 mEq/L | Standard Deviation 15.4 |
| High Velocity Nasal Insufflation | Ventilatory Indices 8 | HCO3 at Treatment Failure | 30.1 mEq/L | Standard Deviation 13.7 |
| High Velocity Nasal Insufflation | Ventilatory Indices 8 | HCO3 at Baseline | 28.6 mEq/L | Standard Deviation 8.6 |
| High Velocity Nasal Insufflation | Ventilatory Indices 8 | HCO3 at 240 min | 26.9 mEq/L | Standard Deviation 6.1 |
| High Velocity Nasal Insufflation | Ventilatory Indices 8 | HCO3 at 60 min | 28.4 mEq/L | Standard Deviation 8.4 |
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.
Time frame: At one and four hours
Population: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 9 | Base excess at Baseline | 2.87 mmol/L | Standard Deviation 7.76 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 9 | Base excess at 60 min | 2.71 mmol/L | Standard Deviation 7.92 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 9 | Base excess at 240 min | 3.14 mmol/L | Standard Deviation 7.79 |
| Noninvasive Positive Pressure Ventilation | Ventilatory Indices 9 | Base excess at Treatment Failure | -2.12 mmol/L | Standard Deviation 13.75 |
| High Velocity Nasal Insufflation | Ventilatory Indices 9 | Base excess at Treatment Failure | 2.29 mmol/L | Standard Deviation 12.88 |
| High Velocity Nasal Insufflation | Ventilatory Indices 9 | Base excess at Baseline | 2.35 mmol/L | Standard Deviation 8.12 |
| High Velocity Nasal Insufflation | Ventilatory Indices 9 | Base excess at 240 min | 1.47 mmol/L | Standard Deviation 5.48 |
| High Velocity Nasal Insufflation | Ventilatory Indices 9 | Base excess at 60 min | 2.3 mmol/L | Standard Deviation 7.95 |