Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery

Respiratory Depression Clinical Trial

Official title:

Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417038
• Other study ID #: 30189
• Status: Completed
• Phase: N/A
• First received: April 10, 2015
• Last updated: May 3, 2017
• Start date: April 2015
• Est. completion date: April 15, 2016

Study information

• Verified date: May 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 15, 2016
• Est. primary completion date: April 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Depression
• Respiratory Insufficiency

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

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

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. — View Citation

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. — View Citation

Kolarzyk E, Szot WM, Lyszczarz J. Lung function and breathing regulation parameters during pregnancy. Arch Gynecol Obstet. 2005 Jun;272(1):53-8. Epub 2004 Dec 23. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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