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An Observational Study of Post-cesarean Delivery Respiratory Patterns Using a Non-invasive Minute Ventilation Monitor (Exspiron ™ System)

Completed
Conditions
Postpartum
Pregnancy
Analgesia
Respiratory Depression
Obstructive Sleep Apnea
Registration Number
NCT02903173
Lead Sponsor
Duke University
Brief Summary

The purpose of this study is to evaluate the breathing patterns of women who undergo cesarean delivery with spinal or epidural morphine for post-operative pain control in the first day after surgery. Some women who undergo cesarean delivery may be at risk for respiratory complications related to opiate administration for post-operative pain. The primary aim of this study is to evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring, and to see if there are predictive risk factors that may predispose women to post-operative hypoventilation.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
54
Inclusion Criteria
  • 18 years or older
  • planned cesarean delivery with neuraxial morphine for post-operative analgesia
Exclusion Criteria
  • Non-English speaking subjects
  • patients who undergo urgent or emergent cesarean deliveries
  • patients who receive general anesthesia or do not receive neuraxial morphine

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in minute ventilationbaseline and 24 hours post cesarian delivery
Secondary Outcome Measures
NameTimeMethod
Berlin QuestionnaireBaseline
STOP-BANG QuestionnaireBaseline
Epworth Sleepiness ScaleBaseline

Trial Locations

Locations (1)

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

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