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NCT02903173 Clinical Trial

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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02903173
Other study ID # Pro00057206
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date June 27, 2018

Study information
Verified date October 2018
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date June 27, 2018
Est. primary completion date June 27, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University Respiratory Motion, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in minute ventilation baseline and 24 hours post cesarian delivery
Secondary Berlin Questionnaire Baseline
Secondary STOP-BANG Questionnaire Baseline
Secondary Epworth Sleepiness Scale Baseline
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