Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02417038

Enrollment

Registered

2015-04-15

Start date

2015-04-30

Completion date

2016-04-15

Last updated

2017-05-04

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

Conditions

Respiratory Depression

Keywords

Postoperative Respiratory Monitoring, Neuraxial Opioid Administration for Cesarean Delivery

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.

Interventions

DEVICECapnostream

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

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