OSA Screen Negative With Spinal Duramorph

NCT ID: NCT03151226

Last Updated: 2018-09-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-03

Study Completion Date

2015-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

capnography monitoring

single arm, all subjects receiving duramorph will receive capnography monitoring

Group Type OTHER

Capnography monitoring

Intervention Type DEVICE

capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Capnography monitoring

capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

pulse oximetry

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter H Pan, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00033095

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Use of On-Q Pump for Pain Post C-Section
NCT02579629 COMPLETED PHASE4