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The pain medication given after major surgery may cause some patients to stop breathing for periods of time especially at night time. An oxygen monitor may reflect this abnormal breathing pattern. This is an observational study of 100 post-operative patients who will be monitored with a pulse oximeter for a minimum of two nights and a maximum of five nights to determine the prevalence of this abnormal breathing pattern.
No further details necessary or available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Major Surgery | Oxygen Monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen Monitoring | Device | No intervention |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert. | Number of patients on the General care Floor in which a SPD (Saturation Pattern Detection) Alert occurs. Each patient wore a sensor on their finger continuously after surgery for up to 5 days. The sensor was attached to a Nellcor N600X oximeter which measures blood oxygen level. A SPD alert detects a patient's blood oxygen level that is increasing and decreasing in a pattern that is associated with periods of no breathing. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE) Caused by no Breathing | Number of participants with Airway Obstruction that caused the patient to stop breathing Number of participants with Cardiac arrest w/resuscitation caused by the patient not breathing | Five Nights |
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Inclusion Criteria:
Exclusion Criteria:
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Hospital Patients
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| Name | Affiliation | Role |
|---|---|---|
| Roger Mecca, MD | Medtronic - MITG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93102 | United States | ||
| Tulane University |
All enrolled patients were included into the trial. This was an observational study.
Patients were recruited from February 12, 2010 to June 25, 2010 from an acute care hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Major Surgery | Post Operative patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Major Surgery | Post Operative patients |
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Adverse Events (AE) Caused by no Breathing | Number of participants with Airway Obstruction that caused the patient to stop breathing Number of participants with Cardiac arrest w/resuscitation caused by the patient not breathing | All enrolled patients | Posted | Number | participants | Five Nights |
|
|
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 | Major Surgery | Post Operative patients |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fran Haury Clinical Program Manager II | Covidien | 303 305-2314 | fran.haury@covidien.com |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| New Orleans |
| Louisiana |
| 70131 |
| United States |
| Texas Health Research & Education Institute | Fort Worth | Texas | 76104 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert. | Number of patients on the General care Floor in which a SPD (Saturation Pattern Detection) Alert occurs. Each patient wore a sensor on their finger continuously after surgery for up to 5 days. The sensor was attached to a Nellcor N600X oximeter which measures blood oxygen level. A SPD alert detects a patient's blood oxygen level that is increasing and decreasing in a pattern that is associated with periods of no breathing. | 93 evaluable patients out of 100 enrolled. | Posted | Number | participants | 5 days |
|
|
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| 0 |
| 100 |
| 0 |
| 100 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |