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This study will include patients who have major surgery and are at risk for or have been diagnosed with sleep apnea. The patients will be monitored the night after surgery for repeating episodes of reduced breathing and oxygen levels. The study will determine if episodes of decreased breathing are reflected in the oxygen monitor.
There is no further detailed description available.
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| Measure | Description | Time Frame |
|---|---|---|
| Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data. | Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects | 12 hour after released from the recovery room |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure. | The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors. | 12 hours after discharge form the recovery room |
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Inclusion Criteria:
Exclusion Criteria:
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Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Roger Mecca, MD | Medtronic - MITG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada | ||
| Toronto Western Hospital |
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From Feb 2010 to Oct 2010 adults at high risk for obstructive sleep apnea scheduled for general surgery requiring analgesia with an expected over night hospital stay were recruited from the hospital clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Surgical Patients At Risk for Obstructive Sleep Apnea | Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Surgical Patients At Risk for Obstructive Sleep Apnea | Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group. |
| 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 | Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data. | Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects | All patients with complete data were analyzed. | Posted | Number | participants | 12 hour after released from the recovery room |
|
30 days
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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 | Adult Surgical Patients At Risk for Obstructive Sleep Apnea | Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fran Haury, RRT Research Coordinator, Clinical Affairs | Covidien | 303 305-2314 | fran.haury@covidien.com |
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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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| Toronto |
| Ontario |
| M5T2S8 |
| Canada |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure. | The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors. | All patients with a positive repetitive reduction in nasal airflow. | Posted | Number | participants | 12 hours after discharge form the recovery room |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |