OSA Screen Negative With Spinal Duramorph

August 8, 2018 updated by: Wake Forest University Health Sciences

A Prospective, Observational, Double-blind (Black-Box) Study Evaluating Incidence, Severity and Predictive Factors of Respiratory Depression and Sleep Disorder Pattern During Postoperative Neuraxial Opioid Analgesia in OSA Screened Negative With BMI>=35 Kg/m2 Obstetric Patients After Cesarean Delivery Using Current Standard Intermittent Postoperative Monitoring Compared to Continuous Pulse Oximetry/Capnography

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Forsyth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: capnography monitoring
single arm, all subjects receiving duramorph will receive capnography monitoring
Device: Capnography monitoring
capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery
Other Names:
  • pulse oximetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Depression/Suppression
Time Frame: up to 24 hours
defined by values obtained utilizing capnography and pulse oximetry
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Peter H Pan, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

May 11, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00033095

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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