N/A
N=177
Predictive Value of the FORE-SIGHT™ Monitor for Hemodynamic Deterioration
Pediatric Congenital Heart Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01706497 ↗Enrolled (actual)
177
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: The Accuracy to Predict Acute Kidney Injury (AKI) Per Patient, 6 Hours Before This Clinical Event (AKI) Occurs — 55 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cerebral tissue oxygen saturation monitoring, blinded (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- KU Leuven
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Accuracy to Predict Acute Kidney Injury (AKI) Per Patient, 6 Hours Before This Clinical Event (AKI) Occurs |
55 | — |
| SECONDARY Hospital Length of Stay |
10 | — |
| SECONDARY Intensive Care Unit Length of Stay |
4 | — |
| SECONDARY Duration of Mechanical Ventilation |
111.3 | — |
| SECONDARY Hospital Mortality |
9 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01706497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.