Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery

NCT02417038 | Completed

• 1 other identifier: 30189
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Depression

Keywords

Postoperative Respiratory Monitoring; Neuraxial Opioid Administration for Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• CO2 monitoring

  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.

  24 hrs

Interventions

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.

Also known as: Capnograph

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women undergoing cesarean delivery with neuraxial anesthesia.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Related Publications (11)

• Clerici C. [Modifications of respiratory function during pregnancy]. Rev Pneumol Clin. 1999 Oct;55(5):307-11. French.

  PMID: 10637899 BACKGROUND

• 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.

  PMID: 15616844 BACKGROUND

• 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.

  PMID: 12860327 BACKGROUND

• 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.

  PMID: 21942973 BACKGROUND

• 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.

  PMID: 22004272 BACKGROUND

• 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.

  PMID: 18500606 BACKGROUND

• 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.

  PMID: 8204230 BACKGROUND

• 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.

  PMID: 23745721 BACKGROUND

• 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.

  PMID: 22003341 BACKGROUND

• Carvalho B. Respiratory depression after neuraxial opioids in the obstetric setting. Anesth Analg. 2008 Sep;107(3):956-61. doi: 10.1213/ane.0b013e318168b443.

  PMID: 18713913 BACKGROUND

• 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.

  PMID: 29958217 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Brendan Carvalho, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: April 15, 2015
• Study Start: April 1, 2015
• Primary Completion: April 15, 2016
• Study Completion: April 15, 2016
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

US (1)