Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep Apnea Hypopnea Syndrome, OSA, Postoperative, CPAP
Brief summary
The purpose of this study is to determine if an Autoadjusting CPAP machine is better than the regular CPAP machine in treatment of Obstructive Sleep Apnea in the postoperative setting.
Detailed description
The purpose of this study is to determine if an Autoadjusting CPAP machine is better than the regular CPAP machine in treatment of Obstructive Sleep Apnea in the postoperative setting. Patients with known Obstructive Sleep Apnea who are on CPAP therapy at home and undergo an elective surgery (meeting specified inclusion and exclusion criteria) will be randomized to either using Autoadjusting CPAP vs their usual CPAP at their prescribed settings the night after surgery. During that night, they will be monitored with full polysomnography in their hospital bed.
Interventions
DEVICEAutoadjusting CPAP (VPAP Auto)
An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the polysomnography study (the first night after surgery).
DEVICECPAP
Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)
Sponsors
ResMed
Great Lakes NeuroTechnologies Inc.
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Known OSA patients well-controlled by CPAP (not hypoxemic i.e. Oxygen Saturation (SaO2) ≥ 89% and post-treatment Apnea Hypopnea (AHI) \<10) and compliant ( \> 3 hours per night) presenting for elective inpatient surgery to MetroHealth Medical Center 2. Elective extremity or lower abdominal surgery 3. Age \>18 years
Exclusion criteria
1. Surgery that may cause hypoxemia from causes other than the effect on upper airway patency e.g. any thoracic surgery, upper abdominal surgery, head and neck surgery. 2. Surgery on the upper-airway. 3. Any condition that may interfere with application of CPAP mask e.g. trauma, surgery on the face, vomiting, naso-gastric intubation etc. 4. OSA treated with a device other than CPAP e.g. Bilevel positive pressure or V-Positive Airway Pressure 5. OSA needing very high levels of CPAP i.e. \> 16 cms to achieve adequate control 6. OSA or other underlying cardiopulmonary conditions that require supplemental oxygen 7. Patients with decompensated congestive heart failure or advanced Chronic Obstructive Pulmonary Disease (COPD) (FEV1\<35% of predicted) 8. Patients with neuromuscular impairment 9. Patients with central sleep apnea 10. Pregnant patients 11. Decisional impaired subjects who are not able to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Related Hypoxemia | On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. | Events are defined as apneas and hypopneas. AHI values are typically categorized as 5-14.9 events/hr = mild; 15-29.9 events/hr = moderate; and \>= 30 events/hr = severe |
| Cardiopulmonary Complications | 72 hours | Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke |
Countries
United States
Participant flow
Recruitment details
Only 11 subjects were recruited but only 8 successfully completed the study (3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep). This resulted in early termination of the study.
Pre-assignment details
No significant events to report.
Participants by arm
| Arm | Count |
|---|---|
| AUTOCPAP An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)
Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery). | 3 |
| CPAP Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)
Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery) | 8 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 3 |
Baseline characteristics
| Characteristic | CPAP | AUTOCPAP | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 3 Participants | 11 Participants |
| Age, Continuous | 52.5 years STANDARD_DEVIATION 7.5 | 50.3 years STANDARD_DEVIATION 9 | 51.2 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment United States | 8 participants | 3 participants | 11 participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 8 |
| other Total, other adverse events | 0 / 3 | 0 / 8 |
| serious Total, serious adverse events | 0 / 3 | 0 / 8 |
Outcome results
Primary
Sleep Related Hypoxemia
Time frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
Population: 3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AUTOCPAP | Sleep Related Hypoxemia | 10.5 Percentage of time < 90% saturation |
| CPAP | Sleep Related Hypoxemia | 7.1 Percentage of time < 90% saturation |
Secondary
Apnea-Hypopnea Index (AHI)
Events are defined as apneas and hypopneas. AHI values are typically categorized as 5-14.9 events/hr = mild; 15-29.9 events/hr = moderate; and \>= 30 events/hr = severe
Time frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
Population: 3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep. Study was terminated early due to enrollment problems.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AUTOCPAP | Apnea-Hypopnea Index (AHI) | 2.1 events per hour |
| CPAP | Apnea-Hypopnea Index (AHI) | 1.2 events per hour |
Secondary
Cardiopulmonary Complications
Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke
Time frame: 72 hours
Population: None in either group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AUTOCPAP | Cardiopulmonary Complications | 0 Participants |
| CPAP | Cardiopulmonary Complications | 0 Participants |