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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02903173
Enrollment
54
Registered
2016-09-16
Start date
2015-02-28
Completion date
2018-06-27
Last updated
2019-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

respiratory depression, postpartum, neuraxial morphine, cesarean delivery

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.

Interventions

None listed

Sponsors

Respiratory Motion, Inc.
CollaboratorINDUSTRY
Duke University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in minute ventilationbaseline and 24 hours post cesarian delivery

Secondary

MeasureTime frame
Berlin QuestionnaireBaseline
STOP-BANG QuestionnaireBaseline
Epworth Sleepiness ScaleBaseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026