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UnknownNCT02884973

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
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
University Hospital, Strasbourg, France · Academic / Other
Sex
All
Age
5 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2016-07-01
Primary completion
2017-06-01
Completion
2017-06-01
First posted
2016-08-31
Last updated
2016-08-31

Source: ClinicalTrials.gov record NCT02884973. Inclusion in this directory is not an endorsement.