Influence of Variations in Systemic Blood Flow and Blood Pressure on Cerebral Oxygenation Measured by Cerebral Oximetry

NCT01424800 | Completed

• 1 other identifier: 2011/208
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study emphasizes on the influence of changes in systemic flow and systemic mean arterial blood pressure (MAP) during cardiopulmonary bypass (CPB) on cerebral oxygenation assessed by near-infrared spectroscopy (NIRS). The aim of the study is to determine whether variations in systemic flow, in MAP, or in both variables at the same time have the greatest impact on the cerebral oxygen saturation.

Conditions

Cerebral Oxygen Saturation

Outcome Measures

Primary Outcomes (2)

• Blood flow

  Changes in blood flow during cerebral oxygen saturation measured with NIRS, during surgery when the patient is on cardiopulmonary bypass.

  during the entire surgery

• Blood pressure

  Changes in blood pressure during cerebral oxygen saturation measured with NIRS, during surgery when the patient is on cardiopulmonary bypass.

  during the entire surgery

Study Arms (1)

change in blood pressure and blood flow

EXPERIMENTAL

34 patients will form the experimental group, in which changes of blood pressure and blood flow will be induced and monitored.

Device: A disposable NIRS (near-infrared spectroscopy) sensor will be applied on the patient's forehead for continuous registration of the cerebral oxygen saturation.

Interventions

A disposable NIRS (near-infrared spectroscopy) sensor will be applied on the patient's forehead for continuous registration of the cerebral oxygen saturation. DEVICE

When the patient is on CPB, pressure and/or flow will be changed while continuously measuring ScO2. Temperature, CO2 , arterial oxygen content, hematocrit and anesthesia will be kept constant during the measurements. First, baseline MAP (mean arterial pressure), baseline ScO2 and baseline central venous oxygen saturation (SvO2) are determined. With the interventions, we will induce a change of 20% in MAP and/or flow. This is within the normal range during operations. Changes in blood pressure will be obtained by the use of vasoactive agents (sodiumnitroprusside for blood pressure decrease and phenylephrine for blood pressure increase). Flow is regulated by manual control of the pump flow. Values of the different variables will be obtained after a 5 min stabilisation period. Flow/pressure interventions will be randomized.

change in blood pressure and blood flow

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-100 years, scheduled for elective cardiac surgery, written informed consent.

You may not qualify if:

• History of cerebrovascular disease or symptomatic carotid artery stenosis.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Annelies Moerman, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 29, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 6, 2012

Record last verified: 2012-03

Locations

BE (1)