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- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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).
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Bukit Timah Road, Singapour, 229899
- KK Women's and Children's Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in cerebral oximetry
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Applicability of a desaturation score in the early detection of adverse outcomes
Délai: 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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Collaborateurs et enquêteurs
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Collaborateurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2015/2161
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