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

NCT01706497 | Completed Results

• 1 other identifier: KUL-S54474
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cerebral tissue oxygen saturation; congenital cardiac surgery; pediatric intensive care unit; Near Infra-Red Spectroscopy; early warning monitor; outcome prediction

Outcome Measures

Primary Outcomes (1)

• The Accuracy to Predict Acute Kidney Injury (AKI) Per Patient, 6 Hours Before This Clinical Event (AKI) Occurs

  Defined according to the Kidney Disease: Improving Global Outcome criteria (AKI stage 2 or 3) * serum creatinine (SCr) level ≥ 2 times the baseline level, or * urine output (UO) \< 0.5 ml/kg/hour for ≥ 12 hours, or * provision of dialysis

  Predictive window of 6 hours before AKI occurence

Secondary Outcomes (4)

• Hospital Length of Stay

  Hospital discharge

• Intensive Care Unit Length of Stay

  Intensive care unit discharge

• Duration of Mechanical Ventilation

  ICU discharge

• Hospital Mortality

  Hospital discharge

Interventions

Cerebral tissue oxygen saturation monitoring, blinded DEVICE

Also known as: Fore-Sight(TM) NIRS

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead
• CAS Medical Systems, Inc.: collaborator

Study Sites (1)

Department of intensive care medicine, university hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (12)

• Pennekamp CW, Bots ML, Kappelle LJ, Moll FL, de Borst GJ. The value of near-infrared spectroscopy measured cerebral oximetry during carotid endarterectomy in perioperative stroke prevention. A review. Eur J Vasc Endovasc Surg. 2009 Nov;38(5):539-45. doi: 10.1016/j.ejvs.2009.07.008. Epub 2009 Aug 7.

  PMID: 19665397 BACKGROUND

• Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G; Collaborative Italian Study Group on Anesthesia in Elderly Patients. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-747. doi: 10.1213/01.ane.0000166974.96219.cd.

  PMID: 16115985 BACKGROUND

• Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.

  PMID: 17179242 BACKGROUND

• Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.

  PMID: 19101265 BACKGROUND

• Phelps HM, Mahle WT, Kim D, Simsic JM, Kirshbom PM, Kanter KR, Maher KO. Postoperative cerebral oxygenation in hypoplastic left heart syndrome after the Norwood procedure. Ann Thorac Surg. 2009 May;87(5):1490-4. doi: 10.1016/j.athoracsur.2009.01.071.

  PMID: 19379890 BACKGROUND

• Hirsch JC, Charpie JR, Ohye RG, Gurney JG. Near-infrared spectroscopy: what we know and what we need to know--a systematic review of the congenital heart disease literature. J Thorac Cardiovasc Surg. 2009 Jan;137(1):154-9, 159e1-12. doi: 10.1016/j.jtcvs.2008.08.005. Epub 2008 Sep 24.

  PMID: 19154918 BACKGROUND

• Uebing A, Furck AK, Hansen JH, Nufer E, Scheewe J, Dutschke P, Jung O, Kramer HH. Perioperative cerebral and somatic oxygenation in neonates with hypoplastic left heart syndrome or transposition of the great arteries. J Thorac Cardiovasc Surg. 2011 Sep;142(3):523-30. doi: 10.1016/j.jtcvs.2011.01.036. Epub 2011 Mar 29.

  PMID: 21450312 BACKGROUND

• Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26.

  PMID: 19176240 BACKGROUND

• Tsien CL, Kohane IS, McIntosh N. Multiple signal integration by decision tree induction to detect artifacts in the neonatal intensive care unit. Artif Intell Med. 2000 Jul;19(3):189-202. doi: 10.1016/s0933-3657(00)00045-2.

  PMID: 10906612 BACKGROUND

• Noble WS. What is a support vector machine? Nat Biotechnol. 2006 Dec;24(12):1565-7. doi: 10.1038/nbt1206-1565.

  PMID: 17160063 BACKGROUND

• Faul S, Gregorcic G, Boylan G, Marnane W, Lightbody G, Connolly S. Gaussian process modeling of EEG for the detection of neonatal seizures. IEEE Trans Biomed Eng. 2007 Dec;54(12):2151-62. doi: 10.1109/tbme.2007.895745.

  PMID: 18075031 BACKGROUND

• Carra G, Flechet M, Jacobs A, Verstraete S, Vlasselaers D, Desmet L, Van Cleemput H, Wouters P, Vanhorebeek I, Van den Berghe G, Guiza F, Meyfroidt G. Postoperative Cerebral Oxygen Saturation in Children After Congenital Cardiac Surgery and Long-Term Total Intelligence Quotient: A Prospective Observational Study. Crit Care Med. 2021 Jun 1;49(6):967-976. doi: 10.1097/CCM.0000000000004852.

  PMID: 33591016 DERIVED

Related Links

• Laboratory of intensive care medicine, KULeuven - University

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Prof Dr Geert Meyfroidt, Associate Professor
• Organization: University Hospitals Leuven (UZ Leuven) and KU Leuven

geert.meyfroidt@uzleuven.be

0032 16 344021

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 15, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 15, 2019
• Results First Posted: May 15, 2019

Record last verified: 2019-05

Locations

BE (1)