Respiratory Failure, Respiratory Insufficiency, Upper Airway Obstruction
Conditions
Keywords
NIV, NIPPV, ventilation
Brief summary
Patients with chronic respiratory failure such as those associated with Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS), Obstructive Sleep Apnea (OSA) or Neuromuscular Disease (NMD) are increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV). The aim of this study is to now compare the Automatic Expiratory Positive Airway Pressure (AutoEPAP) algorithm with a fixed manual EPAP in iVAPS mode on an Astral mixed mode ventilator. It is proposed that the automatic settings of AutoEPAP will be as effective at managing respiratory failure and upper airway obstruction (UAO) as manual EPAP on the Astral device. Specifically demonstrating that the AutoEPAP function is as effective at treating UAO as manual EPAP.
Interventions
DEVICEAstral
Astral ventilator
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients were masked to the mode of treatment. The Core Lab was masked to the mode of treatment for all patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for the study are: 1. Participant has ability to provide written informed consent 2. Participants aged ≥18 years old 3. Participant has documented respiratory failure (e.g. sleep hypoventilation with historical PtCO2 increase ≥ 10mmHg) and/or daytime hypercapnia (\>45 mmHg) 4. Participant is currently using non-invasive positive pressure ventilation in ST or VAPS mode for ≥ 3 months 5. Participants with a previously documented AHI ≥ 5/hr 6. Participants with a recently (≤ 12 months ago) reviewed EPAP setting
Exclusion criteria
for the study are: 1. Participants are not compliant on NIPPV (e.g. \< 4 hr/night) 2. Participants who are pregnant 3. Participants on oxygen therapy ≥5 L/min 4. Participants with an invasive interface (e.g. tracheostomy) 5. Participants who have had an acute exacerbation within the last 3 months that resulted in a hospitalisation 6. Participants who are acutely ill, medically complicated or who are medically unstable 7. Participants in whom NIPPV therapy is otherwise medically contraindicated 8. Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days 9. Participants with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome. 10. Participants who have the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, recent cranial surgery or trauma. 11. Participant does not comprehend English 12. Participant is unable or unwilling to provide written informed consent 13. Participant is physically and/or mentally unable to comply with the protocol 14. Participant is not suitable to participate in the trial for any other reason in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Desaturation Index 4% (ODI4%) | Overnight, up to 8 hrs on nights 1 and 2 | Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency (%) | Overnight, up to 8 hrs on nights 1 and 2 | To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time) |
| Apnea Hypopnea Index (AHI) | Overnight, up 8 hrs on night 1 and 2 | To assess sleep-breathing parameters between groups using mean AHI (#events/hour) |
| Nadir Arterial Oxygen Saturation (SpO2) | Overnight, up 8 hrs on night 1 and 2 | To assess Sleep-breathing parameters between groups using mean SpO2 (%) |
| Arterial Carbon Dioxide (PCO2) | Overnight, up 8 hrs on night 1 and 2 | To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg) |
Countries
United States
Participant flow
Pre-assignment details
43 patients consented for this study. One patient did not meet criteria. 42 patients were randomized and began the first study PSG night. 3 patients were found to be ineligible due to I/E criteria not met. Site erroneously placed patient on ST mode for one of the PSG study nights. Thus, there were 38 patients that were analyzed.
Participants by arm
| Arm | Count |
|---|---|
| Study Total This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both 'Group A' and 'Group B' intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Study Total |
|---|---|
| Age, Continuous | 55.33 years STANDARD_DEVIATION 16.01 |
| BMI | 34.41 kg/m^2 STANDARD_DEVIATION 9.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 0 / 42 | 1 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
Oxygen Desaturation Index 4% (ODI4%)
Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP
Time frame: Overnight, up to 8 hrs on nights 1 and 2
Population: This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both 'Group A' and 'Group B' intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iVAPS With AutoEPAP | Oxygen Desaturation Index 4% (ODI4%) | 3.16 events per hour | Standard Deviation 5.67 |
| iVAPS With Manual EPAP | Oxygen Desaturation Index 4% (ODI4%) | 7.61 events per hour | Standard Deviation 18.87 |
p-value: 0.0134t-test, 1 sided
Secondary
Apnea Hypopnea Index (AHI)
To assess sleep-breathing parameters between groups using mean AHI (#events/hour)
Time frame: Overnight, up 8 hrs on night 1 and 2
Population: Analysis population in each arm/group is based on the total number of participants receiving each intervention over two separate nights.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iVAPS With AutoEPAP | Apnea Hypopnea Index (AHI) | 4.71 events per hour | Standard Deviation 5.55 |
| iVAPS With Manual EPAP | Apnea Hypopnea Index (AHI) | 7.84 events per hour | Standard Deviation 15.39 |
Secondary
Arterial Carbon Dioxide (PCO2)
To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg)
Time frame: Overnight, up 8 hrs on night 1 and 2
Population: Analysis population in each arm/group is based on the total number of participants receiving each intervention over two separate nights.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iVAPS With AutoEPAP | Arterial Carbon Dioxide (PCO2) | 45.49 milimeters of mercury | Standard Deviation 6.62 |
| iVAPS With Manual EPAP | Arterial Carbon Dioxide (PCO2) | 45.38 milimeters of mercury | Standard Deviation 7.17 |
Secondary
Nadir Arterial Oxygen Saturation (SpO2)
To assess Sleep-breathing parameters between groups using mean SpO2 (%)
Time frame: Overnight, up 8 hrs on night 1 and 2
Population: Analysis population in each arm/group is based on the total number of participants receiving each intervention over two separate nights.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iVAPS With AutoEPAP | Nadir Arterial Oxygen Saturation (SpO2) | 94.24 percentage of oxygen saturation | Standard Deviation 2.36 |
| iVAPS With Manual EPAP | Nadir Arterial Oxygen Saturation (SpO2) | 94.53 percentage of oxygen saturation | Standard Deviation 2.78 |
Secondary
Sleep Efficiency (%)
To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time)
Time frame: Overnight, up to 8 hrs on nights 1 and 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iVAPS With AutoEPAP | Sleep Efficiency (%) | 73.70 percentage of total sleep time | Standard Deviation 16.41 |
| iVAPS With Manual EPAP | Sleep Efficiency (%) | 73.89 percentage of total sleep time | Standard Deviation 19.05 |