Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Hypercapnic Acidosis
Conditions
Brief summary
This study will evaluate the ability of High Velocity Nasal Insufflation \[HVNI\] to effect ventilation and related physiologic responses in hypercapnic patients when compared to noninvasive positive pressure ventilation \[NIPPV\].
Detailed description
The overall objective of this randomized study is to evaluate the efficacy of HVNI, in comparison to NIPPV, to clinically stabilize and provide respiratory therapy to patients who have COPD with moderate-to-severe hypercapnic respiratory distress upon presentation. It is hypothesized that HVNI is comparable to NIPPV in the stabilization and relief of moderate-to-severe hypercapnic respiratory distress upon presentation, by relieving the patient's dyspnea (breathlessness) within 4 hours to a comparable degree to NIPPV.
Interventions
The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
Sponsors
Erlanger Baroness Hospital
The Cooper Health System
Dignity Health Medical Foundation
George Washington University
Madigan Army Medical Center
Valley Presbyterian Hospital
University of Maryland
Vapotherm, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults, 18 years or older with a known or suspected diagnosis of COPD * Presentation with acute hypercapnic respiratory failure * Moderate to Severe patient baseline hypercarbia/hypercapnia, defined as a baseline PCO2 of 60 mmHg or higher * Venous pH of 7.0 - 7.35
Exclusion criteria
* Severe metabolic derangements (e.g. suspected drug overdose, mixed acid/base disorder) * Need for airway protection * Primary condition of Congestive Heart Failure * Need for emergent intubation * Pneumonia diagnosis with significant infiltrate on chest x-ray that is clinically correlated with pneumonia * Inability to provide informed consent * Pregnancy * Known contraindication to perform procedures listed, or therapies described in the protocol * Respiratory arrest or significant respiratory depression on presentation * Significant nasal occlusion either unilateral or bilateral * Absence of spontaneous respiration or known contraindication to HVNI * Extreme agitation or uncooperativeness that would hinder either arm of randomized therapy * Determined by the clinician to be sufficiently unstable or unsuitable for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rated Perceived Dyspnea [RPD] | During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min | Patient's subjective assessment of their dyspnea, rated as a modified Borg score on a scale from 0 to 10. Higher scores indicate a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Venous Blood Gas - pH | During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min | pH, measured as units on a pH scale from 0 - 14. Neutral scores indicate a better outcome. |
| Patient Basic Metabolic Panel - Chloride | Baseline, at study start only | Chloride \[Cl-\], measured in mEq/L |
| Patient Basic Metabolic Panel - Lactate | Baseline, at study start only | Lactate, measured in mEq/L |
| Patient Basic Metabolic Panel - Glucose | Baseline, at study start only | Glucose, measured in mg/dL |
| Patient Base Excess - Base Excess | During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min | Base Excess, measured in mEq/L |
| Patient Bicarbonate - Bicarbonate | During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min | Bicarbonate, measured in mEq/L |
| Patient Vital Signs - Heart Rate [HR] | During four time points in the study; Baseline, 30 min, 60 min, and 240 min | Heart rate, measured in beats per minute (bpm) |
| Patient Vital Signs - Respiratory Rate [RR] | During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min | Respiratory rate, measured in breaths per minute (brpm) |
| Patient Vital Signs - Oxygen Saturation [SpO2] | During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min | SpO2 measured as percentage of oxygen saturation (%) |
| Patient Communication Capability - Patient Stability Index | During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min | Patient stability index, measured by patient's ability to speak in full sentences, rated on a 0-100 scale. Higher scores indicate a better outcome. |
| Patient Venous Blood Gas - Venous PCO2 | During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min | Partial pressure of CO2 (PCO2), measured in mmHg |
| Patient Basic Metabolic Panel - Sodium | Baseline, at study start only | Sodium \[Na+\], measured in mEq/L |
| Patient Basic Metabolic Panel - Potassium | Baseline, at study start only | Potassium \[K+\], measured in mEq/L |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinician Perception Score - Expected/Perceived Outcomes | At study end, 4 hours from study start | Clinician's subjective assessment of the expected and perceived patient outcomes as a result of therapy following testing, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. |
| Clinician Perception Score - Patient Comfort/Tolerance | At study end, 4 hours from study start | Clinician's subjective assessment of the patient's comfort and tolerance of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. |
| Clinician Perception Score - Ease of Use | At study end, 4 hours from study start | Clinician's subjective assessment of the ease of use of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. |
| Patient Perception Score - Relief of Symptoms | During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min | Patient's subjective assessment of relief of their symptoms while on therapy, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. |
| Patient Perception Score - Comfort/Tolerance | During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min | Patient's subjective assessment of their comfort and tolerance of therapy during the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Velocity Nasal Insufflation (HVNI) Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress. | 36 |
| Noninvasive Positive Pressure Ventilation (NIPPV) Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress. | 32 |
| Total | 68 |
Baseline characteristics
| Characteristic | High Velocity Nasal Insufflation (HVNI) | Total | Noninvasive Positive Pressure Ventilation (NIPPV) |
|---|---|---|---|
| Age, Continuous | 63.8 Years old STANDARD_DEVIATION 11.18 | 65.96 Years old STANDARD_DEVIATION 10.89 | 67.7 Years old STANDARD_DEVIATION 9.44 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 41 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 12 Participants | 22 Participants | 10 Participants |
| Region of Enrollment United States | 36 participants | 68 participants | 32 participants |
| Sex: Female, Male Female | 16 Participants | 32 Participants | 16 Participants |
| Sex: Female, Male Male | 20 Participants | 36 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 32 |
| other Total, other adverse events | 0 / 36 | 0 / 32 |
| serious Total, serious adverse events | 0 / 36 | 0 / 32 |
Outcome results
Primary
Rated Perceived Dyspnea [RPD]
Patient's subjective assessment of their dyspnea, rated as a modified Borg score on a scale from 0 to 10. Higher scores indicate a worse outcome.
Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Population: The participants had to have an RPD reading at all four time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Rated Perceived Dyspnea [RPD] | Baseline | 5.4 units on a scale (0-10) | Standard Deviation 2.93 |
| High Velocity Nasal Insufflation (HVNI) | Rated Perceived Dyspnea [RPD] | 30 Min | 3.97 units on a scale (0-10) | Standard Deviation 2.82 |
| High Velocity Nasal Insufflation (HVNI) | Rated Perceived Dyspnea [RPD] | 60 Min | 3.09 units on a scale (0-10) | Standard Deviation 2.7 |
| High Velocity Nasal Insufflation (HVNI) | Rated Perceived Dyspnea [RPD] | 240 Min | 3.17 units on a scale (0-10) | Standard Deviation 2.59 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Rated Perceived Dyspnea [RPD] | 240 Min | 3.34 units on a scale (0-10) | Standard Deviation 2.04 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Rated Perceived Dyspnea [RPD] | Baseline | 5.6 units on a scale (0-10) | Standard Deviation 2.41 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Rated Perceived Dyspnea [RPD] | 60 Min | 4.07 units on a scale (0-10) | Standard Deviation 1.77 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Rated Perceived Dyspnea [RPD] | 30 Min | 4.54 units on a scale (0-10) | Standard Deviation 1.65 |
Secondary
Patient Base Excess - Base Excess
Base Excess, measured in mEq/L
Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Population: Patients that had this lab value collected at the timepoints during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Base Excess - Base Excess | Baseline | 6.7 mEq/L | Standard Deviation 4.91 |
| High Velocity Nasal Insufflation (HVNI) | Patient Base Excess - Base Excess | 30 min | 7.43 mEq/L | Standard Deviation 4.52 |
| High Velocity Nasal Insufflation (HVNI) | Patient Base Excess - Base Excess | 240 min | 5.97 mEq/L | Standard Deviation 5.5 |
| High Velocity Nasal Insufflation (HVNI) | Patient Base Excess - Base Excess | 60 min | 6.71 mEq/L | Standard Deviation 4.5 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Base Excess - Base Excess | 240 min | 6.39 mEq/L | Standard Deviation 6.74 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Base Excess - Base Excess | Baseline | 7.7 mEq/L | Standard Deviation 5.56 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Base Excess - Base Excess | 30 min | 7.74 mEq/L | Standard Deviation 7.03 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Base Excess - Base Excess | 60 min | 7.48 mEq/L | Standard Deviation 6.45 |
Secondary
Patient Basic Metabolic Panel - Chloride
Chloride \[Cl-\], measured in mEq/L
Time frame: Baseline, at study start only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Basic Metabolic Panel - Chloride | 97.7 mEq/L | Standard Deviation 6.4 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Basic Metabolic Panel - Chloride | 99.9 mEq/L | Standard Deviation 5.3 |
Secondary
Patient Basic Metabolic Panel - Glucose
Glucose, measured in mg/dL
Time frame: Baseline, at study start only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Basic Metabolic Panel - Glucose | 133.8 mg/dL | Standard Deviation 54.83 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Basic Metabolic Panel - Glucose | 137.2 mg/dL | Standard Deviation 40.03 |
Secondary
Patient Basic Metabolic Panel - Lactate
Lactate, measured in mEq/L
Time frame: Baseline, at study start only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Basic Metabolic Panel - Lactate | 1.6 mEq/L | Standard Deviation 1.25 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Basic Metabolic Panel - Lactate | 1.2 mEq/L | Standard Deviation 0.84 |
Secondary
Patient Basic Metabolic Panel - Potassium
Potassium \[K+\], measured in mEq/L
Time frame: Baseline, at study start only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Basic Metabolic Panel - Potassium | 4.4 mEq/L | Standard Deviation 0.63 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Basic Metabolic Panel - Potassium | 4.4 mEq/L | Standard Deviation 0.66 |
Secondary
Patient Basic Metabolic Panel - Sodium
Sodium \[Na+\], measured in mEq/L
Time frame: Baseline, at study start only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Basic Metabolic Panel - Sodium | 139.9 mEq/L | Standard Deviation 3.5 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Basic Metabolic Panel - Sodium | 140.4 mEq/L | Standard Deviation 3.1 |
Secondary
Patient Bicarbonate - Bicarbonate
Bicarbonate, measured in mEq/L
Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Population: Patients that had this lab value collected during the four time points in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Bicarbonate - Bicarbonate | Baseline | 32.0 mEq/L | Standard Deviation 7.63 |
| High Velocity Nasal Insufflation (HVNI) | Patient Bicarbonate - Bicarbonate | 30 min | 33.18 mEq/L | Standard Deviation 5.61 |
| High Velocity Nasal Insufflation (HVNI) | Patient Bicarbonate - Bicarbonate | 60 min | 32.75 mEq/L | Standard Deviation 5.69 |
| High Velocity Nasal Insufflation (HVNI) | Patient Bicarbonate - Bicarbonate | 240 min | 30.93 mEq/L | Standard Deviation 8.73 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Bicarbonate - Bicarbonate | 240 min | 32.18 mEq/L | Standard Deviation 7.35 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Bicarbonate - Bicarbonate | Baseline | 33.8 mEq/L | Standard Deviation 6.6 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Bicarbonate - Bicarbonate | 60 min | 32.45 mEq/L | Standard Deviation 8.11 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Bicarbonate - Bicarbonate | 30 min | 32.43 mEq/L | Standard Deviation 9.86 |
Secondary
Patient Communication Capability - Patient Stability Index
Patient stability index, measured by patient's ability to speak in full sentences, rated on a 0-100 scale. Higher scores indicate a better outcome.
Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Population: Patients that had the Stability Index collected during the four time points in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Communication Capability - Patient Stability Index | Baseline | 62.00 units on a scale (0-100) | Standard Deviation 28 |
| High Velocity Nasal Insufflation (HVNI) | Patient Communication Capability - Patient Stability Index | 30 min | 73.81 units on a scale (0-100) | Standard Deviation 18.79 |
| High Velocity Nasal Insufflation (HVNI) | Patient Communication Capability - Patient Stability Index | 60 min | 77.75 units on a scale (0-100) | Standard Deviation 17.97 |
| High Velocity Nasal Insufflation (HVNI) | Patient Communication Capability - Patient Stability Index | 240 min | 82.28 units on a scale (0-100) | Standard Deviation 17.67 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Communication Capability - Patient Stability Index | 240 min | 82.00 units on a scale (0-100) | Standard Deviation 19.37 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Communication Capability - Patient Stability Index | Baseline | 62.50 units on a scale (0-100) | Standard Deviation 23.09 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Communication Capability - Patient Stability Index | 60 min | 76.48 units on a scale (0-100) | Standard Deviation 15.78 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Communication Capability - Patient Stability Index | 30 min | 68.92 units on a scale (0-100) | Standard Deviation 17.23 |
Secondary
Patient Venous Blood Gas - pH
pH, measured as units on a pH scale from 0 - 14. Neutral scores indicate a better outcome.
Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Population: Patients that had this lab value collected during the four time points in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Venous Blood Gas - pH | Baseline | 7.27 pH | Standard Deviation 0.06 |
| High Velocity Nasal Insufflation (HVNI) | Patient Venous Blood Gas - pH | 30 min | 7.3 pH | Standard Deviation 0.06 |
| High Velocity Nasal Insufflation (HVNI) | Patient Venous Blood Gas - pH | 60 min | 7.31 pH | Standard Deviation 0.06 |
| High Velocity Nasal Insufflation (HVNI) | Patient Venous Blood Gas - pH | 240 min | 7.31 pH | Standard Deviation 0.06 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Venous Blood Gas - pH | 240 min | 7.31 pH | Standard Deviation 0.06 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Venous Blood Gas - pH | Baseline | 7.27 pH | Standard Deviation 0.04 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Venous Blood Gas - pH | 60 min | 7.3 pH | Standard Deviation 0.07 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Venous Blood Gas - pH | 30 min | 7.28 pH | Standard Deviation 0.06 |
Secondary
Patient Venous Blood Gas - Venous PCO2
Partial pressure of CO2 (PCO2), measured in mmHg
Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Population: Patients that had PCO2 collected during the four time points during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Venous Blood Gas - Venous PCO2 | Baseline | 77.8 mmHg | Standard Deviation 13.6 |
| High Velocity Nasal Insufflation (HVNI) | Patient Venous Blood Gas - Venous PCO2 | 30 min | 72.56 mmHg | Standard Deviation 15.71 |
| High Velocity Nasal Insufflation (HVNI) | Patient Venous Blood Gas - Venous PCO2 | 60 min | 71.19 mmHg | Standard Deviation 14.85 |
| High Velocity Nasal Insufflation (HVNI) | Patient Venous Blood Gas - Venous PCO2 | 240 min | 68.76 mmHg | Standard Deviation 13.68 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Venous Blood Gas - Venous PCO2 | 240 min | 67.29 mmHg | Standard Deviation 20.03 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Venous Blood Gas - Venous PCO2 | Baseline | 76.5 mmHg | Standard Deviation 13.6 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Venous Blood Gas - Venous PCO2 | 60 min | 70.95 mmHg | Standard Deviation 19.56 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Venous Blood Gas - Venous PCO2 | 30 min | 73.22 mmHg | Standard Deviation 19.04 |
Secondary
Patient Vital Signs - Heart Rate [HR]
Heart rate, measured in beats per minute (bpm)
Time frame: During four time points in the study; Baseline, 30 min, 60 min, and 240 min
Population: Patients who had their Heart Rate collected during the four time points in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Vital Signs - Heart Rate [HR] | Baseline | 93.2 BPM | Standard Deviation 17.37 |
| High Velocity Nasal Insufflation (HVNI) | Patient Vital Signs - Heart Rate [HR] | 30 min | 90.78 BPM | Standard Deviation 15.5 |
| High Velocity Nasal Insufflation (HVNI) | Patient Vital Signs - Heart Rate [HR] | 60 min | 90.03 BPM | Standard Deviation 14.25 |
| High Velocity Nasal Insufflation (HVNI) | Patient Vital Signs - Heart Rate [HR] | 240 min | 91.22 BPM | Standard Deviation 14.45 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Vital Signs - Heart Rate [HR] | 240 min | 82.40 BPM | Standard Deviation 17.92 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Vital Signs - Heart Rate [HR] | Baseline | 85.9 BPM | Standard Deviation 16.58 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Vital Signs - Heart Rate [HR] | 60 min | 84.04 BPM | Standard Deviation 14.34 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Vital Signs - Heart Rate [HR] | 30 min | 87.24 BPM | Standard Deviation 21.02 |
Secondary
Patient Vital Signs - Oxygen Saturation [SpO2]
SpO2 measured as percentage of oxygen saturation (%)
Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Population: Patients who had their SPO2 collected during the four timepoints in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Vital Signs - Oxygen Saturation [SpO2] | Baseline | 94.4 percentage of oxygen saturation | Standard Deviation 7.42 |
| High Velocity Nasal Insufflation (HVNI) | Patient Vital Signs - Oxygen Saturation [SpO2] | 30 min | 95.69 percentage of oxygen saturation | Standard Deviation 3.46 |
| High Velocity Nasal Insufflation (HVNI) | Patient Vital Signs - Oxygen Saturation [SpO2] | 60 min | 95.78 percentage of oxygen saturation | Standard Deviation 3.08 |
| High Velocity Nasal Insufflation (HVNI) | Patient Vital Signs - Oxygen Saturation [SpO2] | 240 min | 95.56 percentage of oxygen saturation | Standard Deviation 2.91 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Vital Signs - Oxygen Saturation [SpO2] | 240 min | 97.16 percentage of oxygen saturation | Standard Deviation 3.44 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Vital Signs - Oxygen Saturation [SpO2] | Baseline | 96.8 percentage of oxygen saturation | Standard Deviation 3.37 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Vital Signs - Oxygen Saturation [SpO2] | 60 min | 97.28 percentage of oxygen saturation | Standard Deviation 3.29 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Vital Signs - Oxygen Saturation [SpO2] | 30 min | 96.80 percentage of oxygen saturation | Standard Deviation 3.89 |
Secondary
Patient Vital Signs - Respiratory Rate [RR]
Respiratory rate, measured in breaths per minute (brpm)
Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Population: Patients who had their Respiratory Rate collected during the four different timepoints in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Vital Signs - Respiratory Rate [RR] | Baseline | 20.9 Breaths per min | Standard Deviation 5 |
| High Velocity Nasal Insufflation (HVNI) | Patient Vital Signs - Respiratory Rate [RR] | 60 min | 20.56 Breaths per min | Standard Deviation 5.3 |
| High Velocity Nasal Insufflation (HVNI) | Patient Vital Signs - Respiratory Rate [RR] | 30 min | 21.13 Breaths per min | Standard Deviation 6.41 |
| High Velocity Nasal Insufflation (HVNI) | Patient Vital Signs - Respiratory Rate [RR] | 240 min | 20.97 Breaths per min | Standard Deviation 4.82 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Vital Signs - Respiratory Rate [RR] | 240 min | 20.92 Breaths per min | Standard Deviation 6.3 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Vital Signs - Respiratory Rate [RR] | Baseline | 21.2 Breaths per min | Standard Deviation 6.09 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Vital Signs - Respiratory Rate [RR] | 30 min | 22.12 Breaths per min | Standard Deviation 6.9 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Vital Signs - Respiratory Rate [RR] | 60 min | 21.32 Breaths per min | Standard Deviation 7.05 |
Other Pre-specified
Clinician Perception Score - Ease of Use
Clinician's subjective assessment of the ease of use of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Time frame: At study end, 4 hours from study start
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Clinician Perception Score - Ease of Use | 16.45 units on a scale | Standard Deviation 16.25 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Clinician Perception Score - Ease of Use | 15.08 units on a scale | Standard Deviation 18.68 |
Other Pre-specified
Clinician Perception Score - Expected/Perceived Outcomes
Clinician's subjective assessment of the expected and perceived patient outcomes as a result of therapy following testing, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Time frame: At study end, 4 hours from study start
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Clinician Perception Score - Expected/Perceived Outcomes | 23.26 units on a scale | Standard Deviation 14.33 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Clinician Perception Score - Expected/Perceived Outcomes | 16.32 units on a scale | Standard Deviation 14.52 |
Other Pre-specified
Clinician Perception Score - Patient Comfort/Tolerance
Clinician's subjective assessment of the patient's comfort and tolerance of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Time frame: At study end, 4 hours from study start
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Clinician Perception Score - Patient Comfort/Tolerance | 17.58 units on a scale | Standard Deviation 13.61 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Clinician Perception Score - Patient Comfort/Tolerance | 22.04 units on a scale | Standard Deviation 20.87 |
Other Pre-specified
Patient Perception Score - Comfort/Tolerance
Patient's subjective assessment of their comfort and tolerance of therapy during the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Population: Patients who had their score collected during the four different timepoints in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Perception Score - Comfort/Tolerance | Baseline | 34.8 units on a scale | Standard Deviation 24.81 |
| High Velocity Nasal Insufflation (HVNI) | Patient Perception Score - Comfort/Tolerance | 30 min | 28.39 units on a scale | Standard Deviation 22.53 |
| High Velocity Nasal Insufflation (HVNI) | Patient Perception Score - Comfort/Tolerance | 60 min | 22.35 units on a scale | Standard Deviation 19.49 |
| High Velocity Nasal Insufflation (HVNI) | Patient Perception Score - Comfort/Tolerance | 240 min | 20.13 units on a scale | Standard Deviation 23.45 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Perception Score - Comfort/Tolerance | 240 min | 43.25 units on a scale | Standard Deviation 32.02 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Perception Score - Comfort/Tolerance | Baseline | 38.5 units on a scale | Standard Deviation 22.19 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Perception Score - Comfort/Tolerance | 60 min | 42.41 units on a scale | Standard Deviation 28.3 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Perception Score - Comfort/Tolerance | 30 min | 44.82 units on a scale | Standard Deviation 24.41 |
Other Pre-specified
Patient Perception Score - Relief of Symptoms
Patient's subjective assessment of relief of their symptoms while on therapy, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Population: Patients that had this data collected at the four time points during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Patient Perception Score - Relief of Symptoms | Baseline | 34.8 units on a scale | Standard Deviation 24.81 |
| High Velocity Nasal Insufflation (HVNI) | Patient Perception Score - Relief of Symptoms | 30 min | 28.45 units on a scale | Standard Deviation 22.26 |
| High Velocity Nasal Insufflation (HVNI) | Patient Perception Score - Relief of Symptoms | 60 min | 24.68 units on a scale | Standard Deviation 19.86 |
| High Velocity Nasal Insufflation (HVNI) | Patient Perception Score - Relief of Symptoms | 240 min | 28.48 units on a scale | Standard Deviation 24.09 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Perception Score - Relief of Symptoms | 240 min | 24.58 units on a scale | Standard Deviation 21.8 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Perception Score - Relief of Symptoms | Baseline | 38.5 units on a scale | Standard Deviation 22.19 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Perception Score - Relief of Symptoms | 60 min | 27.82 units on a scale | Standard Deviation 20.1 |
| Noninvasive Positive Pressure Ventilation (NIPPV) | Patient Perception Score - Relief of Symptoms | 30 min | 38.05 units on a scale | Standard Deviation 19.91 |