- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94304
- Lucile Packard Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CO2 monitoring
Time Frame: 24 hrs
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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.
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24 hrs
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brendan Carvalho, MD, Stanford University
Publications and helpful links
General Publications
- Carvalho B. Respiratory depression after neuraxial opioids in the obstetric setting. Anesth Analg. 2008 Sep;107(3):956-61. doi: 10.1213/ane.0b013e318168b443.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30189
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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