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- Klinische proef NCT02417259
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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Bukit Timah Road, Singapore, 229899
- KK Women's and Children's Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in cerebral oximetry
Tijdsspanne: 48horus post-operatively
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To show if there is a delayed increase in cerebral oximetry post-operation as compared SpO2 and PaO2 which occur immediately
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48horus post-operatively
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Change in somatic oximetry
Tijdsspanne: 48hours post-operatively
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To show if there is a delayed increase in somatic oximetry post-operation as compared SpO2 and PaO2 which occur immediately
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48hours post-operatively
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Applicability of a desaturation score in the early detection of adverse outcomes
Tijdsspanne: 48hours post-operatively
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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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48hours post-operatively
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Medewerkers en onderzoekers
Medewerkers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2015/2161
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