Near Infrared Spectroscopy in Cyanotic Congenital Heart Disease

Congenital Heart Defects Clinical Trial

Official title:

Changes in Cerebral and Somatic Near Infrared Spectroscopy Monitoring Before and After Surgery for in Children With Cyanotic Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417259
• Other study ID #: 2015/2161
• Status: Completed
• First received: April 10, 2015
• Last updated: March 31, 2018
• Start date: July 2015
• Est. completion date: April 2018

Study information

• Verified date: March 2018
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Bukit Timah Road

Sponsors (2)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	Covidien Private Limited

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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