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OpenTrials
Completed

NCT Number: NCT02903173

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

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.

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Key information

Conditions

Pregnancy Agnosia Analgesia Apnea Dyssomnias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Obstructive Sleep Apnea Pathological Conditions, Signs and Symptoms Perceptual Disorders Postpartum Respiration Disorders Respiratory Depression Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in minute ventilation

    Time frame: baseline and 24 hours post cesarian delivery

Secondary outcomes

  1. Berlin Questionnaire

    Time frame: Baseline

  2. STOP-BANG Questionnaire

    Time frame: Baseline

  3. Epworth Sleepiness Scale

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Respiratory Motion, Inc.

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2016
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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