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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02473978
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
sharonorbach, Rabin Medical Center

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
Anoxia 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.

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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 : April 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Group/Cohort 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.




Primary Outcome Measures :
  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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All women undergoing cesarean section in Beilinson Hospital.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473978


Locations
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Israel
Beilinson hospital
Petach tikvah, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: sharon orbach, md Rabin Medical Center
Publications:

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Responsible Party: sharonorbach, Doctor, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02473978    
Other Study ID Numbers: 0113-15-RMC
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016
Keywords provided by sharonorbach, Rabin Medical Center:
During Labor
Complicating Anesthesia or Other Sedation
Cerebral
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory