Near Infrared Spectroscopy in Cyanotic Congenital Heart Disease
Changes in Cerebral and Somatic Near Infrared Spectroscopy Monitoring Before and After Surgery for in Children With Cyanotic Heart Disease
1 other identifier
observational
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2015
CompletedFirst Posted
Study publicly available on registry
April 15, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 3, 2018
March 1, 2018
11 months
April 10, 2015
March 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in cerebral oximetry
To show if there is a delayed increase in cerebral oximetry post-operation as compared SpO2 and PaO2 which occur immediately
48horus post-operatively
Change in somatic oximetry
To show if there is a delayed increase in somatic oximetry post-operation as compared SpO2 and PaO2 which occur immediately
48hours post-operatively
Secondary Outcomes (1)
Applicability of a desaturation score in the early detection of adverse outcomes
48hours post-operatively
Eligibility Criteria
Children with cyanotic congenital heart disease undergoing cardiac surgery
You may qualify if:
- Pre-operative diagnosis of cyanotic congenital heart disease
- Undergoing any form of cardiac surgery
- Informed consent was given by the caregiver/parent
You may not qualify if:
- Premature infants \<35 weeks corrected age who will be cared for in the neonatal ICU postoperatively
- Congenital lactic acidosis syndromes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KK Women's and Children's Hospitallead
- Covidien Private Limitedcollaborator
Study Sites (1)
KK Women's and Children's Hospital
Bukit Timah Road, Singapore, 229899, Singapore
Related Publications (1)
Wong JJ, Chen CK, Moorakonda RB, Wijeweera O, Tan TYS, Nakao M, Allen JC Jr, Loh TF, Lee JH. Changes in Near-Infrared Spectroscopy After Congenital Cyanotic Heart Surgery. Front Pediatr. 2018 Apr 13;6:97. doi: 10.3389/fped.2018.00097. eCollection 2018.
PMID: 29707528DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MBBCh BAO, MRCPCH
Study Record Dates
First Submitted
April 10, 2015
First Posted
April 15, 2015
Study Start
July 1, 2015
Primary Completion
June 1, 2016
Study Completion
April 1, 2018
Last Updated
April 3, 2018
Record last verified: 2018-03