Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery

Completed

• Conditions: Respiratory Depression

• Registration Number: NCT02417038
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-15
• Primary Completion: 2016-04-15
• Study Completion: 2016-04-15
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CO2 monitoring	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.

Trial Locations

Locations (1)

Lucile Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States