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

NCT02884973 | Unknown

• 1 other identifier: 6156
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congenital Heart Defect

Keywords

congenital heart; NIRS

Outcome Measures

Primary Outcomes (1)

• oxygen saturation in brain and kidney tissue

  1 hour after cardiac surgery

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged under 5 years who underwent cardiac surgery (palliative or curative) and postoperative hospital period in pediatric resuscitation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Anne-Sophie Guilbert, MD

CONTACT

33 (0)3 88 12 73 20; anne-sophie.guilbert@chru-strasbourg.fr

Nicolas Mura, MD

CONTACT

33 (0)3 88 12 73 20; Nicolas.mura@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: August 31, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 31, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share