Predictive Value of the FORE-SIGHT™ Monitor for Hemodynamic Deterioration
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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. |
- 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
- 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) |
-
Device: Cerebral tissue oxygen saturation monitoring, blinded
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 |
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).
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| 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 |
| Belgium | |
| Department of intensive care medicine, university hospitals Leuven | Recruiting |
| Leuven, Belgium, 3000 | |
| Principal Investigator: Geert JP Meyfroidt, MD, PhD | |
| 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 June 18, 2013