Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery
NCT ID: NCT02417038
Last Updated: 2017-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2015-04-30
2016-04-15
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Capnostream
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 45
* Gestational age greater than 37 completed weeks
* Singleton pregnancy.
Exclusion Criteria
* 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.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Stanford University
OTHER
Responsible Party
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Brendan Carvalho
Principle Investigator
Principal Investigators
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Brendan Carvalho, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Lucile Packard Children's Hospital
Palo Alto, California, United States
Countries
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References
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Clerici C. [Modifications of respiratory function during pregnancy]. Rev Pneumol Clin. 1999 Oct;55(5):307-11. French.
Kolarzyk E, Szot WM, Lyszczarz J. Lung function and breathing regulation parameters during pregnancy. Arch Gynecol Obstet. 2005 Jun;272(1):53-8. doi: 10.1007/s00404-004-0691-1. Epub 2004 Dec 23.
Trakada G, Tsapanos V, Spiropoulos K. Normal pregnancy and oxygenation during sleep. Eur J Obstet Gynecol Reprod Biol. 2003 Aug 15;109(2):128-32. doi: 10.1016/s0301-2115(03)00100-3.
Sultan P, Gutierrez MC, Carvalho B. Neuraxial morphine and respiratory depression: finding the right balance. Drugs. 2011 Oct 1;71(14):1807-19. doi: 10.2165/11596250-000000000-00000.
Grindheim G, Toska K, Estensen ME, Rosseland LA. Changes in pulmonary function during pregnancy: a longitudinal cohort study. BJOG. 2012 Jan;119(1):94-101. doi: 10.1111/j.1471-0528.2011.03158.x. Epub 2011 Oct 18.
Kato R, Shimamoto H, Terui K, Yokota K, Miyao H. Delayed respiratory depression associated with 0.15 mg intrathecal morphine for cesarean section: a review of 1915 cases. J Anesth. 2008;22(2):112-6. doi: 10.1007/s00540-007-0593-z. Epub 2008 May 25.
Pan PH, James CF. Anesthetic-postoperative morphine regimens for cesarean section and postoperative oxygen saturation monitored by a telemetric pulse oximetry network for 24 continuous hours. J Clin Anesth. 1994 Mar-Apr;6(2):124-8. doi: 10.1016/0952-8180(94)90009-4.
Wilson DL, Walker SP, Fung AM, O'Donoghue F, Barnes M, Howard M. Can we predict sleep-disordered breathing in pregnancy? The clinical utility of symptoms. J Sleep Res. 2013 Dec;22(6):670-8. doi: 10.1111/jsr.12063. Epub 2013 Jun 10.
Silva GE, Vana KD, Goodwin JL, Sherrill DL, Quan SF. Identification of patients with sleep disordered breathing: comparing the four-variable screening tool, STOP, STOP-Bang, and Epworth Sleepiness Scales. J Clin Sleep Med. 2011 Oct 15;7(5):467-72. doi: 10.5664/JCSM.1308.
Carvalho B. Respiratory depression after neuraxial opioids in the obstetric setting. Anesth Analg. 2008 Sep;107(3):956-61. doi: 10.1213/ane.0b013e318168b443.
Weiniger CF, Akdagli S, Turvall E, Deutsch L, Carvalho B. Prospective Observational Investigation of Capnography and Pulse Oximetry Monitoring After Cesarean Delivery With Intrathecal Morphine. Anesth Analg. 2019 Mar;128(3):513-522. doi: 10.1213/ANE.0000000000003503.
Other Identifiers
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30189
Identifier Type: -
Identifier Source: org_study_id
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