Predictive Value of the FORE-SIGHT™ Monitor for Hemodynamic Deterioration
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|ClinicalTrials.gov Identifier: NCT01706497|
Recruitment Status : Completed
First Posted : October 15, 2012
Last Update Posted : September 27, 2016
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 or disease||Intervention/treatment|
|Pediatric Congenital Heart Surgery||Device: Cerebral tissue oxygen saturation monitoring, blinded|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|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.|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Device: Cerebral tissue oxygen saturation monitoring, blinded
- 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 ]
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
- Hospital length of stay [ Time Frame: Hospital discharge ]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 ]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 ]participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks
- Hospital mortality [ Time Frame: Hospital discharge ]participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks
- ICU mortality [ Time Frame: ICU discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706497
|Department of intensive care medicine, university hospitals Leuven|
|Leuven, Belgium, 3000|
|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|