Respiratory Depression
Conditions
Keywords
obstructive sleep apnea screen negative, respiratory depression, cesarean section
Brief summary
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.
Interventions
DEVICECapnography monitoring
capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* OSA screen negative per hospital protocol * age 18 or greater * BMI\>35 * consent to participate to wear capnography and pulse oximetry monitoring devices post delivery
Exclusion criteria
* Spanish speaking only * under age 18 * contraindication to receiving drugs utilized in delivery anesthetic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Depression/Suppression | up to 24 hours | defined by values obtained utilizing capnography and pulse oximetry |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | not wear device correctly | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Capnography Monitoring |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Respiratory Depression/Suppression
defined by values obtained utilizing capnography and pulse oximetry
Time frame: up to 24 hours
Population: the 2 subjects who wore device did not wear the device enough to be evaluable data