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Completed

NCT Number: NCT02417038

Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery

Respiratory depression occurs in labor and delivery; noticeably when neuraxial opioids are given.Pathophysiological respiratory depression -failure to respond to hypercapnia or hypoxia - is challenging to measure clinically.American Society of Anesthesiologist guidelines recommend suitable respiratory monitoring for 24 hours post cesarean delivery (CD).

Use of capnograph will enable us to assess breath-by-breathe respiration in a population receiving neuraxial opioids - potentially at risk for respiratory depression.

Our aim is to assess our ability to capture maternal postpartum respiratory parameters in a cohort following opioid neuraxial administration for CD.

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Key information

Conditions

Respiratory Depression Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

About this study

The investigators wish to test the efficacy of capnograph in detection of apnea and respiratory depression in women following cesarean delivery. Currently, routine intensive monitoring such as the investigators propose is not performed, and many apneas may go undetected.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • American Society of Anesthesiologists physical status class I or II
  • Age between 18 and 45
  • Gestational age greater than 37 completed weeks
  • Singleton pregnancy.

Exclusion criteria

  • Contraindication for neuraxial analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
  • Allergies to postoperative medication (opioids, NSAIDs, acetaminophen)
  • Chronic opioid use
  • Opioid administration in the previous 12 hours
  • Inability to adequately understand the consent form
  • Blocked nose or nasal deformity.

Treatment and study plan

Capnostream

Device

The Capnostream capnograph (is registered with the FDA) is supplied by Covidien. The Capnostream is a portable CO2 monitor with a pulse oximetry module to measure and record SpO2 (oxygen saturation) and heart rate continuously. The Capnostream provides waveform patterns for respiratory rate and EtCO2 measurement.

Other names: Capnograph

Primary outcomes

  1. CO2 monitoring

    Time frame: 24 hrs

    The Capnostream is a portable CO2 monitor with a pulse oximetry module to measure and record SpO2 and heart rate and provides waveform patterns for respratory rate and EtCO2 measurement.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2015
Registry last updated
May 4, 2017

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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