Trial Outcomes & Findings for OSA Screen Negative With Spinal Duramorph (NCT NCT03151226)

Last Updated: 2018-09-07

Results Overview

defined by values obtained utilizing capnography and pulse oximetry

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

up to 24 hours

Results posted on

2018-09-07

Participant milestones
Measure	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
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	2
Overall Study not wear device correctly	1

OSA Screen Negative With Spinal Duramorph

Baseline characteristics by cohort
Measure	Capnography Monitoring n=3 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

Timeframe: up to 24 hours

Population: the 2 subjects who wore device did not wear the device enough to be evaluable data

defined by values obtained utilizing capnography and pulse oximetry

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Wake Forest School of Medicine

Phone: 336-718-8278