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

Clalit Health Services

Status: Completed

Conditions: Anoxia

Treatments: Device: INVOS Cerebral Oximetry

Study type: Observational

Funder types: Other

Identifiers

NCT02473978

0113-15-RMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

84 participants in 2 patient groups

Participants undergoing cesarean sections

Description:

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.

Treatment:

Device: INVOS Cerebral Oximetry

Participants throughout cesarean sections

Description:

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.

Treatment:

Device: INVOS Cerebral Oximetry