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

Anoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02473978
• Other study ID #: 0113-15-RMC
• Status: Not yet recruiting
• Phase: N/A
• First received: June 11, 2015
• Last updated: June 16, 2015
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Rabin Medical Center
• Contact: sharon orbach, md
• Phone: 054-538-3093
• Email: sharonorbach[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anoxia

Intervention

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

Locations

Country	Name	City	State
Israel	Beilinson hospital	Petach tikvah
Israel	Beilinson hospital	Petach tikvah

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (20)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Gibson AP, Hebden JC, Arridge SR. Recent advances in diffuse optical imaging. Phys Med Biol. 2005 Feb 21;50(4):R1-43. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Villringer A, Chance B. Non-invasive optical spectroscopy and imaging of human brain function. Trends Neurosci. 1997 Oct;20(10):435-42. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No