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Difficulty with enrollment
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| Name | Class |
|---|---|
| ResMed | INDUSTRY |
| Great Lakes NeuroTechnologies Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autoadjusting CPAP (VPAP auto) | Experimental | The intervention will be the use of an Autoadjusting CPAP unit that will be applied to the subject during the 8 hours overnight the first night after surgery (study night). During this time, they will undergo a full night attended polysomnogram in their hospital room. |
|
| CPAP arm (usual care) | Active Comparator | The intervention will be the use of the subject's own CPAP machine and this will be applied to the subject during the 8 hours overnight the first after surgery (study night). During the study night, they will undergo full polysomnography in their hospital room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autoadjusting CPAP (VPAP Auto) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Related Hypoxemia | On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inderjeet S Brar, MD | MetroHealth Medical Center, Case Western Reserve University | Principal Investigator |
| Dennis Auckley, MD | MetroHealth Medical Center, Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11991871 | Background | Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080. | |
| 2122773 | Background | Bailey PL, Pace NL, Ashburn MA, Moll JW, East KA, Stanley TH. Frequent hypoxemia and apnea after sedation with midazolam and fentanyl. Anesthesiology. 1990 Nov;73(5):826-30. doi: 10.1097/00000542-199011000-00005. |
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No significant events to report.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Sleep Related Hypoxemia | 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. | Posted | Mean | Full Range | Percentage of time < 90% saturation | On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. |
|
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Method for collection was to include chart review for prespecified adverse events.
0 adverse events were recorded during the study.
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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 | 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). |
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Trial limitations include:
1. Insufficient enrollment to adequately analyze data
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dennis Auckley | MetroHealth Medical Center | 216-778-7212 | dauckley@metrohealth.org |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| CPAP | Device | Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery) |
|
| Cardiopulmonary Complications |
Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke |
| 72 hours |
| 9249130 | Background | Ostermeier AM, Roizen MF, Hautkappe M, Klock PA, Klafta JM. Three sudden postoperative respiratory arrests associated with epidural opioids in patients with sleep apnea. Anesth Analg. 1997 Aug;85(2):452-60. doi: 10.1097/00000539-199708000-00037. No abstract available. |
| 11560300 | Background | Gupta RM, Parvizi J, Hanssen AD, Gay PC. Postoperative complications in patients with obstructive sleep apnea syndrome undergoing hip or knee replacement: a case-control study. Mayo Clin Proc. 2001 Sep;76(9):897-905. doi: 10.4065/76.9.897. |
| 16645462 | Background | Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT, Cote CJ, Nickinovich DG, Prachand V, Ward DS, Weaver EM, Ydens L, Yu S; American Society of Anesthesiologists Task Force on Perioperative Management. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2006 May;104(5):1081-93; quiz 1117-8. doi: 10.1097/00000542-200605000-00026. No abstract available. |
| BG001 |
| 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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) |
|
|
| 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 | 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. | Posted | Mean | Full Range | events per hour | On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. |
|
|
|
| Secondary | Cardiopulmonary Complications | Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke | None in either group | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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) | 0 | 8 | 0 | 8 | 0 | 8 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |