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Predictive Value of the FORE-SIGHT™ Monitor for Hemodynamic Deterioration

NCT01706497 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2019-05-15

Study results available
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Summary

The postoperative period after congenital heart surgery in children can be a very critical episode, where it is of utmost importance to closely monitor the circulation in these patients. Invasive hemodynamic monitoring tools available in the adult population, are often not suitable to use in small children.

The Fore-Sight(TM) is a non-invasive monitor for brain tissue oxygenation (SctO2), by projecting harmless near-infrared light trough the skin, skull, and brain via a disposable sensor that is applied on the forehead of patients. In many centres, the Fore-Sight (TM) is part of the routine monitoring of children during cardio-pulmonary bypass for congenital heart surgery. Although the monitor has not been tested for this purpose, it is often continued in the postoperative phase in the intensive care unit (ICU), where it is used to monitor the hemodynamic situation of the patient.

The purpose of the present study is to examine and validate the use of the Fore-Sight monitor for hemodynamic monitoring of children in the postoperative phase after cardiac surgery.

The study hypothesis is whether SctO2 desaturations are predictive for future hemodynamic deterioration of the patient, and whether these SctO2 desaturations are predictive for the outcome of these patients.

Conditions

  • Pediatric Congenital Heart Surgery

Interventions

DEVICE

Cerebral tissue oxygen saturation monitoring, blinded

Sponsors & Collaborators

  • CAS Medical Systems, Inc.

    collaborator INDUSTRY

  • KU Leuven

    lead OTHER

Principal Investigators

  • Geert JP Meyfroidt, MD, PhD · Department of Intensive Care Medicine, University Hospitals Leuven, Belgium and Laboratory of intensive care medicine, department of cellular and molecular medicine, Biomedical sciences group, KULeuven - University, Belgium

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-01-31
Completion
2016-01-31

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 NCT01706497 on ClinicalTrials.gov