Respiratory DepressionNCT02417038

Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery

An observational study of Respiratory Depression, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Respiratory Depression
What is being tested?: Capnostream
Type of treatment: Medical device
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Apr 2015to 15 Apr 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Study population: Women undergoing cesarean delivery with neuraxial anesthesia.

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Lucile Packard Children's Hospital
Palo Alto, California, 94304

Other trials in United States

About this study

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.

Read the 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.

Conditions: Respiratory Depression
Being tested: Capnostream
Keywords: Postoperative Respiratory Monitoring, Neuraxial Opioid Administration for Cesarean Delivery
Medical subject headings: Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CapnostreamDevice
Also called Capnograph
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201515 Apr 2016

First posted15 Apr 2015 (estimated)
Study startApr 2015
Primary completion15 Apr 2016
Study completion15 Apr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Respiratory DepressionStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02417038
Sponsor's protocol ID: 30189
Status last verified: May 2017
First submitted: 10 Apr 2015
Last updated: 4 May 2017
Results posted: No
Data monitoring committee: No

Publications

Clerici C. [Modifications of respiratory function during pregnancy]. Rev Pneumol Clin. 1999 Oct;55(5):307-11. French.
PubMed 10637899
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.
PubMed 15616844
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.
PubMed 12860327
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.
PubMed 21942973
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.
PubMed 22004272
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.
PubMed 18500606
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.
PubMed 8204230
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.
PubMed 23745721
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.
PubMed 22003341
Carvalho B. Respiratory depression after neuraxial opioids in the obstetric setting. Anesth Analg. 2008 Sep;107(3):956-61. doi: 10.1213/ane.0b013e318168b443.
PubMed 18713913
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.
PubMed 29958217

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery
ClinicalTrials.gov ID: NCT02417038
Acronym / sponsor ID: 30189
Conditions: Respiratory Depression
Keywords: Postoperative Respiratory Monitoring, Neuraxial Opioid Administration for Cesarean Delivery
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: Apr 2015 (actual)
Primary completion: 15 Apr 2016 (actual)
Study completion: 15 Apr 2016 (actual)
First posted: 15 Apr 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Women undergoing cesarean delivery with neuraxial anesthesia.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CapnostreamAlso: CapnographThe 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.	Device	–

Primary outcome

CO2 monitoring
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
Background: PubMed 10637899Clerici C. [Modifications of respiratory function during pregnancy]. Rev Pneumol Clin. 1999 Oct;55(5):307-11. French.
Background: PubMed 15616844Kolarzyk 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.
Background: PubMed 12860327Trakada 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.
Background: PubMed 21942973Sultan 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.
Background: PubMed 22004272Grindheim 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.
Background: PubMed 18500606Kato 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.
Background: PubMed 8204230Pan 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.
Background: PubMed 23745721Wilson 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.
Background: PubMed 22003341Silva 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.
Background: PubMed 18713913Carvalho B. Respiratory depression after neuraxial opioids in the obstetric setting. Anesth Analg. 2008 Sep;107(3):956-61. doi: 10.1213/ane.0b013e318168b443.
Derived from this study: PubMed 29958217Weiniger 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brendan Carvalho, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Depression, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CO2 monitoring (time frame: 24 hrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02417038, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.