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

September 20, 2019 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

54

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
      • Durham, North Carolina, United States, 27710
        • Duke University 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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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 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

Cohorts and Interventions

Group / Cohort
Women who undergo cesarean delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in minute ventilation
Time Frame: baseline and 24 hours post cesarian delivery
baseline and 24 hours post cesarian delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Berlin Questionnaire
Time Frame: Baseline
Baseline
STOP-BANG Questionnaire
Time Frame: Baseline
Baseline
Epworth Sleepiness Scale
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

Duke University

Collaborators

Respiratory Motion, Inc.

Investigators

  • Principal Investigator: Jennifer Dominguez, Duke University

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

February 1, 2015

Primary Completion (ACTUAL)

June 27, 2018

Study Completion (ACTUAL)

June 27, 2018

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (ESTIMATE)

September 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00057206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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