Prospective Evaluation of Changes in Tissue Oxygen Saturation in Brain and Kidney in Children Admitted to Intensive Care in the Postoperative Period of Cardiac Surgery

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02884973

Enrollment

Registered

2016-08-31

Start date

2016-07-31

Completion date

2017-06-30

Last updated

2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Defect

Keywords

congenital heart, NIRS

Brief summary

It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of live births, 5,000 new cases per year currently in France These are serious diseases that can be life-threatening to more or less short term. The advances in surgical techniques in recent years has improved the prognosis of these patients in the first months of life. The success of surgery is, among other things, conditioned by a support per complex operation, involving a multimodal intensive monitoring, and respiratory and hemodynamic support techniques. These elements of surveillance, NIRS (Near-infrared spectroscopy) allows measurement of non-invasive tissue saturation (rSO2) in cerebral and renal oxygen. The fundamental principle of NIRS based on an estimate of the percentage proportion of cerebral oxy-hemoglobin. A light source is emitted by NIRS and through body tissues to the brain where the light will be absorbed and refracted depending on the tissue composition in oxy-hemoglobin. Refracted light will be analyzed by NIRS which in turn using software will help to determine a percentage of oxyhemoglobin. Normal values of cerebral NIRS are between 50 and 80%.NIRS can be used according to this principle to estimate cerebral tissue oxygenation but also for other tissues such as the kidney. More than the figure, those are changes NIRS compared to a baseline that will alert us to the conditions of tissue oxygenation and allow us to identify hypoxia times. Changes in the value of the NIRS depends on 3 criteria: the tissue blood flow, the percentage of oxyhemoglobin and deoxyhemoglobin percentage.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 5 Years

Healthy volunteers

Inclusion criteria

* Children under 5 years * Allowed in pediatric intensive care unit * Having received heart surgery for management of congenital heart disease

Exclusion criteria

* Patients aged over 5 years * Violations preexisting brain to the intervention (brain malformation) * Patients with congenital heart disease and admitted to intensive care for reasons other than the surgical treatment of heart disease

Design outcomes

Primary

Measure	Time frame
oxygen saturation in brain and kidney tissue	1 hour after cardiac surgery

Contacts

Primary ContactAnne-Sophie Guilbert, MD

anne-sophie.guilbert@chru-strasbourg.fr33 (0)3 88 12 73 20

Backup ContactNicolas Mura, MD

Nicolas.mura@chru-strasbourg.fr33 (0)3 88 12 73 20

Outcome results