- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02884973
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
oxygen saturation in brain and kidney tissue
Time Frame: 1 hour after cardiac surgery
|
1 hour after cardiac surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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