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CompletedNCT02473978Updated May 10, 2016

Cerebral Near-infrared Spectroscopy (NIRS) Monitoring Throughout Caesarean Deliveries

An observational study in Anoxia, sponsored by Rabin Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-10.

Sponsored by Rabin Medical Center · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
84
Ages
18 Years and older
Sex
Female
01

Study summary

In this study the investigator would like to examine hemodynamic cerebral blood flow and brain function by the use of Invos cerebral oximetry in women undergoing cesarean section delivery.

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.

Read the detailed description

This is a prospective, single center study which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. The Institutional Review Board has approved this study.

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.

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Conditions studied

  • Anoxia

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Keywords

  • During Labor
  • Complicating Anesthesia or Other Sedation
  • Cerebral
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In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 84 is above the median of 67 across 335 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All women undergoing cesarean section in Beilinson Hospital.

Inclusion criteria

  • All women undergoing cesarean section in Beilinson Hospital following obtaining written informed consents forums with the ability to comply to the study requirements will be included in our study.

Exclusion criteria

Exclusion Criteria:

  • Women under age 18 , and women who don't understand the inform consent form will be excluded from participating.
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Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
84 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Device: INVOS Cerebral Oximetry

  • 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.

    Device: INVOS Cerebral Oximetry

Interventions

  • DeviceINVOS Cerebral Oximetry

    Participants will be connected to INVOS Cerebral Oximetry Cerebral Oximetry preoperativly and intraoperativly to ascess there cerebral perfusion throughout cesarean sections.

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What researchers measure

Primary outcomes

  1. measure the cerebral perfusion in participants undergoing cesarean sections deliveries, under spinal anesthesia, epidural anesthesia, and general anesthesia

    Time frame: The average time frame is 24 hours.

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Study locations

1 site
  • Beilinson hospital
    Petach tikvah, Israel
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References and documents

Publications

  • Calderon-Arnulphi M, Alaraj A, Slavin KV. Near infrared technology in neuroscience: past, present and future. Neurol Res. 2009 Jul;31(6):605-14. doi: 10.1179/174313209X383286. PubMed 19660190 ↗
  • 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. PubMed 19340120 ↗
  • 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. PubMed 9347608 ↗
  • Boas DA, Dale AM, Franceschini MA. Diffuse optical imaging of brain activation: approaches to optimizing image sensitivity, resolution, and accuracy. Neuroimage. 2004;23 Suppl 1:S275-88. doi: 10.1016/j.neuroimage.2004.07.011. PubMed 15501097 ↗
  • Gibson AP, Hebden JC, Arridge SR. Recent advances in diffuse optical imaging. Phys Med Biol. 2005 Feb 21;50(4):R1-43. doi: 10.1088/0031-9155/50/4/r01. PubMed 15773619 ↗
  • Gratton E, Toronov V, Wolf U, Wolf M, Webb A. Measurement of brain activity by near-infrared light. J Biomed Opt. 2005 Jan-Feb;10(1):11008. doi: 10.1117/1.1854673. PubMed 15847574 ↗
  • 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. PubMed 18397905 ↗
  • 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. PubMed 20007987 ↗
  • 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. PubMed 17179242 ↗
  • 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. PubMed 17410713 ↗
  • 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. PubMed 9524894 ↗
  • 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. PubMed 12464528 ↗
  • 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. PubMed 17893451 ↗
  • 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. PubMed 15515298 ↗
  • 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. PubMed 15767985 ↗
  • 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. PubMed 17622209 ↗
  • 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. PubMed 23144435 ↗
  • 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. PubMed 22104067 ↗
  • 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. PubMed 9641334 ↗
  • 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. PubMed 25557591 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02473978
Lead sponsor
Rabin Medical Center
Responsible party
sharonorbach (Doctor, Rabin Medical Center) — Principal investigator
First posted
Jun 17, 2015
Start date
Apr 2015
Primary completion
Apr 2016
Completion
Apr 2016
Last update
May 10, 2016

Study contacts

sharon orbach, md
principal investigator · Rabin Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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