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Technical difficulty and feasibility issues
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Non emergent scheduled cesarean sections will be consented to participate in this study of patients who have screened negative for obstructive sleep apnea and who are also BMI>/= 35 to have capnography monitoring postoperatively. The capnography and pulse oximetry will be initiated in the post anesthesia care unit and be worn for 12-24 hours after delivery. Data will be retrieved after that time period in a deidentified fashion. Medication usage will be reviewed as well as the standard of care information from the duramorph monitoring will be retrieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| capnography monitoring | Other | single arm, all subjects receiving duramorph will receive capnography monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capnography monitoring | Device | capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Depression/Suppression | defined by values obtained utilizing capnography and pulse oximetry | up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter H Pan, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Capnography Monitoring | single arm, all subjects receiving duramorph will receive capnography monitoring Capnography monitoring: capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Capnography Monitoring | single arm, all subjects receiving duramorph will receive capnography monitoring Capnography monitoring: capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery |
| 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 | Respiratory Depression/Suppression | defined by values obtained utilizing capnography and pulse oximetry | the 2 subjects who wore device did not wear the device enough to be evaluable data | Posted | up to 24 hours |
|
|
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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 | Capnography Monitoring | single arm, all subjects receiving duramorph will receive capnography monitoring Capnography monitoring: capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter H. Pan | Wake Forest School of Medicine | 336-718-8278 | ppan@wakehealth.edu |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D010092 | Oximetry |
| ID | Term |
|---|---|
| D001784 | Blood Gas Analysis |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
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| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D008919 | Investigative Techniques |