Cerebral Near-infrared Spectroscopy (NIRS) Monitoring Throughout Caesarean Deliveries
NCT ID: NCT02473978
Last Updated: 2016-05-10
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
84 participants
OBSERVATIONAL
2015-04-30
2016-04-30
Brief Summary
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This study is a purely observational study, it will not have any clinical intervention nor will it interfere with standard cesarean delivery protocols in any way.
The investigator's primary objective is to evaluate how anesthesia influences cerebral blood flow perfusion during cesarean section deliveries.
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Detailed Description
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Two hundred women undergoing cesarean sections will be enrolled after filling out an informed consent form.
Cerebral blood flow perfusion will be monitored preoperatively, intraoperativly and half an hour postoperativly, for all enrolled participants using INVOS Cerebral Oximetry.
Preoperative data will be compared to intraoperative data and analyzed in order to evaluate the dynamic cerebral oxygen and blood perfusion changes in women undergoing cesarean sections.
Conditions
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Study Design
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CASE_CROSSOVER
CROSS_SECTIONAL
Study Groups
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Participants undergoing cesarean sections
The participants preoperative data will be compared to intraoperative data and analyzed in order to evaluate the dynamic cerebral oxygen and blood perfusion changes in participants undergoing cesarean sections.
INVOS Cerebral Oximetry
Participants will be connected to INVOS Cerebral Oximetry Cerebral Oximetry preoperativly and intraoperativly to ascess there cerebral perfusion throughout cesarean sections.
Participants throughout cesarean sections
The participants intraoperative data will be compared to preoperative data and analyzed in order to evaluate the dynamic cerebral oxygen and blood perfusion changes in participants undergoing cesarean sections.
INVOS Cerebral Oximetry
Participants will be connected to INVOS Cerebral Oximetry Cerebral Oximetry preoperativly and intraoperativly to ascess there cerebral perfusion throughout cesarean sections.
Interventions
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INVOS Cerebral Oximetry
Participants will be connected to INVOS Cerebral Oximetry Cerebral Oximetry preoperativly and intraoperativly to ascess there cerebral perfusion throughout cesarean sections.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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sharonorbach
Doctor
Principal Investigators
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sharon orbach, md
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Beilinson hospital
Petach Tikvah, , Israel
Countries
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References
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Huppert TJ, Diamond SG, Franceschini MA, Boas DA. HomER: a review of time-series analysis methods for near-infrared spectroscopy of the brain. Appl Opt. 2009 Apr 1;48(10):D280-98. doi: 10.1364/ao.48.00d280.
Villringer A, Chance B. Non-invasive optical spectroscopy and imaging of human brain function. Trends Neurosci. 1997 Oct;20(10):435-42. doi: 10.1016/s0166-2236(97)01132-6.
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Fischer GW. Recent advances in application of cerebral oximetry in adult cardiovascular surgery. Semin Cardiothorac Vasc Anesth. 2008 Mar;12(1):60-9. doi: 10.1177/1089253208316443. Epub 2008 Apr 7.
Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299.
Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.
Calderon-Arnulphi M, Alaraj A, Amin-Hanjani S, Mantulin WW, Polzonetti CM, Gratton E, Charbel FT. Detection of cerebral ischemia in neurovascular surgery using quantitative frequency-domain near-infrared spectroscopy. J Neurosurg. 2007 Feb;106(2):283-90. doi: 10.3171/jns.2007.106.2.283.
Carlin RE, McGraw DJ, Calimlim JR, Mascia MF. The use of near-infrared cerebral oximetry in awake carotid endarterectomy. J Clin Anesth. 1998 Mar;10(2):109-13. doi: 10.1016/s0952-8180(97)00252-3.
Hirofumi O, Otone E, Hiroshi I, Satosi I, Shigeo I, Yasuhiro N, Masato S. The effectiveness of regional cerebral oxygen saturation monitoring using near-infrared spectroscopy in carotid endarterectomy. J Clin Neurosci. 2003 Jan;10(1):79-83. doi: 10.1016/s0967-5868(02)00268-0.
Moritz S, Kasprzak P, Arlt M, Taeger K, Metz C. Accuracy of cerebral monitoring in detecting cerebral ischemia during carotid endarterectomy: a comparison of transcranial Doppler sonography, near-infrared spectroscopy, stump pressure, and somatosensory evoked potentials. Anesthesiology. 2007 Oct;107(4):563-9. doi: 10.1097/01.anes.0000281894.69422.ff.
Vets P, ten Broecke P, Adriaensen H, Van Schil P, De Hert S. Cerebral oximetry in patients undergoing carotid endarterectomy: preliminary results. Acta Anaesthesiol Belg. 2004;55(3):215-20.
Yamamoto K, Komiyama T, Miyata T, Kitagawa T, Momose T, Shigematsu H, Nagawa H. Contralateral stenosis as a risk factor for carotid endarterectomy measured by near infrared spectroscopy. Int Angiol. 2004 Dec;23(4):388-93.
Yamamoto K, Miyata T, Nagawa H. Good correlation between cerebral oxygenation measured using near infrared spectroscopy and stump pressure during carotid clamping. Int Angiol. 2007 Sep;26(3):262-5.
Ghosh A, Elwell C, Smith M. Review article: cerebral near-infrared spectroscopy in adults: a work in progress. Anesth Analg. 2012 Dec;115(6):1373-83. doi: 10.1213/ANE.0b013e31826dd6a6. Epub 2012 Nov 9.
Joshi B, Ono M, Brown C, Brady K, Easley RB, Yenokyan G, Gottesman RF, Hogue CW. Predicting the limits of cerebral autoregulation during cardiopulmonary bypass. Anesth Analg. 2012 Mar;114(3):503-10. doi: 10.1213/ANE.0b013e31823d292a. Epub 2011 Nov 21.
Daubeney PE, Smith DC, Pilkington SN, Lamb RK, Monro JL, Tsang VT, Livesey SA, Webber SA. Cerebral oxygenation during paediatric cardiac surgery: identification of vulnerable periods using near infrared spectroscopy. Eur J Cardiothorac Surg. 1998 Apr;13(4):370-7. doi: 10.1016/s1010-7940(98)00024-4.
Kenosi M, Naulaers G, Ryan CA, Dempsey EM. Current research suggests that the future looks brighter for cerebral oxygenation monitoring in preterm infants. Acta Paediatr. 2015 Mar;104(3):225-31. doi: 10.1111/apa.12906. Epub 2015 Jan 29.
Other Identifiers
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0113-15-RMC
Identifier Type: -
Identifier Source: org_study_id
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