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

NCT02903173 | Completed

• 1 other identifier: Pro00057206
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Analgesia; Respiratory Depression; Obstructive Sleep Apnea; Postpartum

Keywords

respiratory depression; postpartum; neuraxial morphine; cesarean delivery

Outcome Measures

Primary Outcomes (1)

• Change in minute ventilation

  baseline and 24 hours post cesarian delivery

Secondary Outcomes (3)

• Berlin Questionnaire

  Baseline

• STOP-BANG Questionnaire

  Baseline

• Epworth Sleepiness Scale

  Baseline

Study Arms (1)

Women who undergo cesarean delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be pregnant woman recruited from the Duke Birthing Center (DBC) in the 5700 unit of Duke Hospital who are scheduled for planned cesarean delivery.

You may qualify if:

• years or older
• planned cesarean delivery with neuraxial morphine for post-operative analgesia

You may not qualify if:

• Non-English speaking subjects
• patients who undergo urgent or emergent cesarean deliveries
• patients who receive general anesthesia or do not receive neuraxial morphine

Sponsors & Collaborators

• Duke University: lead
• Respiratory Motion, Inc.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Agnosia; Respiratory Insufficiency; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Sleep Apnea Syndromes; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Jennifer Dominguez

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: February 1, 2015
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: September 24, 2019

Record last verified: 2018-10

Locations

US (1)