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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Defects

Detailed Description

NIRS has been used to predict short term clinical outcomes (low cardiac output states, prolonged ventilation, and prolonged hospital stay) and long term clinical outcomes (reduced neurodevelopmental scores at 1year, radiological changes on magnetic resonance imaging). NIRS has also been tested against traditional markers of global tissue perfusion like mixed venous saturation and serum lactate, however, results from these studies are mixed. There is insufficient prospective data evaluating NIRs with direct clinical outcomes and uncertainty about the threshold value or the duration below a threshold value that leads to tissue injury. Because of this lack of data, the benefit and risk of management strategies targeted to improve NIRS values remains unknown.

We will characterize the time series of cerebral and somatic oximetry, pulse oximetry and partial pressure of arterial oxygen in the cyanotic child undergoing surgical repair of a congenital heart defect. We will then determine the correlation between the time series if any. This new information will advance our understanding of the hemodynamic changes that occur in the perioperative period and may lead to new therapeutic targets.

The primary hypothesis is that there is a delayed increase in cerebral and somatic oximetry post-operation as compared pulse oximetry (SpO2) and partial pressure of arterial oxygen (PaO2) which occur immediately.

The secondary hypothesis is to establish the applicability of a desaturation score (decrease of 20% in area under the curve [AUC] over an hour) in the early prediction of adverse outcomes.

The oximetry probes will be placed pre-induction of anesthesia (to determine baseline) and recordings will be continuous throughout the operation and 48hours post-operatively. Children undergoing cardiac surgery generally stay in the hospital for 1-2weeks. We will also take oximetry measurements prior to discharge from hospital (to determine the new steady state). Sites measured are cerebral (forehead) and somatic (left flank).

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Singapore
  • Bukit Timah Road, Singapore, 229899
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with cyanotic congenital heart disease undergoing cardiac surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Applicability of a desaturation score in the early detection of adverse outcomes	Cerebral desaturation score (>20% decrease in AUC over an hour) for early detection of adverse outcome such as cardiorespiratory deterioration requiring chest tube insertion, re-do surgery, chest compressions, electrical shock or initiation of extracorporeal membrane oxygenation.	48hours post-operatively

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: Covidien Private Limited

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 10, 2015
• First Posted (Estimate): April 15, 2015

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: March 31, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Spectroscopy, Near-Infrared
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 2015/2161