Near Infrared Spectroscopy in Cyanotic Congenital Heart Disease
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|ClinicalTrials.gov Identifier: NCT02417259|
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : April 3, 2018
|Condition or disease|
|Congenital Heart Defects|
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|
|Actual Enrollment :||40 participants|
|Official Title:||Changes in Cerebral and Somatic Near Infrared Spectroscopy Monitoring Before and After Surgery for in Children With Cyanotic Heart Disease|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||April 2018|
- Change in cerebral oximetry [ Time Frame: 48horus post-operatively ]To show if there is a delayed increase in cerebral oximetry post-operation as compared SpO2 and PaO2 which occur immediately
- Change in somatic oximetry [ Time Frame: 48hours post-operatively ]To show if there is a delayed increase in somatic oximetry post-operation as compared SpO2 and PaO2 which occur immediately
- Applicability of a desaturation score in the early detection of adverse outcomes [ Time Frame: 48hours post-operatively ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417259
|KK Women's and Children's Hospital|
|Bukit Timah Road, Singapore, 229899|