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

Sponsor
Rabin Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02473978
Collaborator
(none)
84
1
12
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: INVOS Cerebral Oximetry

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.

Study Design

Study Type:
Observational
Actual Enrollment :
84 participants
Observational Model:
Case-Crossover
Time Perspective:
Cross-Sectional
Official Title:
Cerebral Near-infrared Spectroscopy (NIRS) Monitoring Throughout Caesarean Deliveries
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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 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.

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.

Outcome Measures

Primary Outcome Measures

  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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beilinson hospital Petach tikvah Israel

Sponsors and Collaborators

  • Rabin Medical Center

Investigators

  • Principal Investigator: sharon orbach, md, Rabin Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
sharonorbach, Doctor, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT02473978
Other Study ID Numbers:
  • 0113-15-RMC
First Posted:
Jun 17, 2015
Last Update Posted:
May 10, 2016
Last Verified:
May 1, 2016
Keywords provided by sharonorbach, Doctor, Rabin Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2016