CompletedNot Applicable

Near Infrared Spectroscopy in Cyanotic Congenital Heart Disease

Singapore40 participantsStarted 2015-07

Plain-language summary

We are conducting a prospective cohort study of 20 children with cyanotic congenital heart disease who are admitted for cardiac surgery. We will record cerebral and somatic near infrared spectroscopy (NIRS) at two sites - forehead and flank regions using the Covidien INVOS™ 5100C Cerebral / Somatic Oximeter. The monitoring will begin one hour pre-operatively (baseline) and continue until 48hours post-operatively. We will also take measurements prior to discharge from hospital. Baseline demographics, physiological and laboratory variables will be recorded. Clinical outcome variables including mortality, duration of intensive care unit (ICU) stay, duration of mechanical ventilation, inotropic support and feed tolerance will also be recorded.

Who can participate

Age range1 Day – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pre-operative diagnosis of cyanotic congenital heart disease * Undergoing any form of cardiac surgery * Informed consent was given by the caregiver/parent Exclusion Criteria: * Premature infants \<35 weeks corrected age who will be cared for in the neonatal ICU postoperatively * Congenital lactic acidosis syndromes

What they're measuring

Change in cerebral oximetry

Timeframe: 48horus post-operatively

Change in somatic oximetry

Timeframe: 48hours post-operatively

Trial details

NCT IDNCT02417259

SponsorKK Women's and Children's Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2016-06

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