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

NCT02473978 | Completed

• 1 other identifier: 0113-15-RMC
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anoxia

Keywords

During Labor; Complicating Anesthesia or Other Sedation; Cerebral

Outcome Measures

Primary Outcomes (1)

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

  The average time frame is 24 hours.

Study Arms (2)

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

INVOS Cerebral Oximetry DEVICE

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; Participants undergoing cesarean sections

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women undergoing cesarean section in Beilinson Hospital.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Beilinson hospital

Petach Tikvah, Israel

Location

Related Publications (20)

• 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.

  PMID: 19660190 BACKGROUND

• 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.

  PMID: 19340120 BACKGROUND

• 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.

  PMID: 9347608 BACKGROUND

• 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.

  PMID: 15501097 BACKGROUND

• 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.

  PMID: 15773619 BACKGROUND

• 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.

  PMID: 15847574 BACKGROUND

• 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.

  PMID: 18397905 BACKGROUND

• 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.

  PMID: 20007987 BACKGROUND

• 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.

  PMID: 17179242 BACKGROUND

• 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.

  PMID: 17410713 BACKGROUND

• 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.

  PMID: 9524894 BACKGROUND

• 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.

  PMID: 12464528 BACKGROUND

• 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.

  PMID: 17893451 BACKGROUND

• 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.

  PMID: 15515298 BACKGROUND

• 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.

  PMID: 15767985 BACKGROUND

• 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.

  PMID: 17622209 BACKGROUND

• 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.

  PMID: 23144435 BACKGROUND

• 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.

  PMID: 22104067 BACKGROUND

• 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.

  PMID: 9641334 BACKGROUND

• 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.

  PMID: 25557591 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• sharon orbach, md

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 17, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 10, 2016

Record last verified: 2016-05

Locations

IL (1)