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

NCT01424800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-03-06

No results posted yet for this study

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

Interventions

DEVICE

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

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.

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Annelies Moerman, MD · University Hospital, Ghent

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01424800 on ClinicalTrials.gov