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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Katholieke Universiteit Leuven
Sponsor:
Collaborator:
CAS Medical Systems, Inc.
Information provided by (Responsible Party):
Geert Meyfroidt, MD, PhD, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01706497
First received: October 10, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Pediatric Congenital Heart Surgery
Device: Cerebral tissue oxygen saturation monitoring, blinded

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the Predictive Value of the FORE-SIGHT™ Monitor for Early Detection of Hemodynamic Deterioration After Pediatric Cardiac Surgery. A Data-mining Study.

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Episodes of hemodynamic instability [ Time Frame: predictive window of 10 minutes; patients will be followed as long as they are mechanically ventilated, an expected average of 1-4days ] [ Designated as safety issue: No ]

    If one of more of the following criteria is met, this is considered to be an episode of hemodynamic instability:

    Hemodynamic monitoring criteria

    • Heart Rate >160 or <90, for at least 5 consecutive minutes
    • Systolic Blood Pressure < 55 (infants) or < 65 (children) , for at least 5 consecutive minutes Point of care laboratory analysis criteria
    • Venous Saturation (SvO2) <55 (when cyanogenic cardiopathy is present), or <65 (in all other patients)
    • Lactate > 2 mmol/L on arterial blood gas sampling Clinical observation criteria
    • Urine Output rate < normal rate of 0.5 ml/kg/h over 2 consecutive hours


Secondary Outcome Measures:
  • Hospital length of stay [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks

  • Intensive care unit length of stay [ Time Frame: Intensive care unit discharge ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks

  • Duration of mechanical ventilation [ Time Frame: ICU discharge ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks

  • Hospital mortality [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks

  • ICU mortality [ Time Frame: ICU discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Cerebral tissue oxygen saturation monitoring, blinded
    Other Name: Fore-Sight(TM) NIRS
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All children younger than 12 years, admitted after cardiac surgery in the pediatric intensive care unit (PICU) of the university hospitals Leuven, Belgium, on mechanical ventilation or intubated after admission. Children are monitored with the FORE-SIGHT™, from admission until they are weaned off mechanical ventilation (typically, most of these patients are mechanically ventilated between 12 hours and two weeks after ICU admission).

Criteria

Inclusion Criteria:

  • younger than 12 years of age
  • Mechanically ventilated upon ICU admission or intubated after admission
  • arterial line in place
  • expected to stay at least 24 hous in the PICU

Exclusion Criteria:

  • actual or potential brain damage (such as traumatic brain injury, brain tumors, or patients after cardiopulmonary resuscitation (CPR), ...).
  • patients with a condition or a wound that prohibits the placement of a forehead sensor are also excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706497

Contacts
Contact: Geert JP Meyfroidt, MD, PhD +32 16 344021 geert.meyfroidt@uzleuven.be
Contact: Fabian Güiza Grandas, PhD +32 16 344232 fabian.guiza@med.kuleuven.be

Locations
Belgium
Department of intensive care medicine, university hospitals Leuven Recruiting
Leuven, Belgium, 3000
Principal Investigator: Geert JP Meyfroidt, MD, PhD         
Sponsors and Collaborators
Katholieke Universiteit Leuven
CAS Medical Systems, Inc.
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Publications:

Responsible Party: Geert Meyfroidt, MD, PhD, Assistant Professor, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01706497     History of Changes
Other Study ID Numbers: KUL-S54474
Study First Received: October 10, 2012
Last Updated: November 8, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Katholieke Universiteit Leuven:
cerebral tissue oxygen saturation
congenital cardiac surgery
pediatric intensive care unit
Near Infra-Red Spectroscopy
early warning monitor
outcome prediction

ClinicalTrials.gov processed this record on August 01, 2014