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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
Sponsor:
Collaborator:
Covidien Private Limited
Information provided by (Responsible Party):
Judith Wong Ju-Ming, KK Women's and Children's Hospital

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.

Condition or disease
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).


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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with cyanotic congenital heart disease undergoing cardiac surgery
Criteria

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

Information from the National Library of Medicine

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


Locations
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Singapore
KK Women's and Children's Hospital
Bukit Timah Road, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
Covidien Private Limited

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Judith Wong Ju-Ming, MBBCh BAO, MRCPCH, KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02417259     History of Changes
Other Study ID Numbers: 2015/2161
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018

Keywords provided by Judith Wong Ju-Ming, KK Women's and Children's Hospital:
Spectroscopy, Near-Infrared

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities