Near-infrared spectroscopy to monitor cerebral and renal oxygen saturation during cardiopulmonary bypass surgery for paediatric congenital heart disease: study protocol for a prospective observational cohort trial
Background Current indicators for monitoring intraoperative organ function remain predominantly indirect, delayed and non-specific, particularly in paediatric populations undergoing congenital heart surgery, where multifactorial influences further complicate functional assessments. Emerging evidence...
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| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2025-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/4/e097459.full |
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| Summary: | Background Current indicators for monitoring intraoperative organ function remain predominantly indirect, delayed and non-specific, particularly in paediatric populations undergoing congenital heart surgery, where multifactorial influences further complicate functional assessments. Emerging evidence suggests that the use of near-infrared spectroscopy (NIRS) technology to continuously monitor the regional oxygen saturation (rSO₂) of intraoperative organs can predict the postoperative organ functional status. This study aims to investigate the associations between intraoperative cerebral/renal rSO₂ fluctuations monitored by NIRS and postoperative neurological injury or acute kidney injury (AKI) in paediatric congenital heart disease (CHD) surgery.Methods and analysis In this prospective observational cohort study, patients ≤18 years, scheduled for CHD surgery under cardiopulmonary bypass (CPB), will be enrolled after obtaining written informed consent. Exclusion criteria include pre-existing neuropsychiatric disorders, chronic kidney disease or other related disorders. Dual-channel NIRS probes will be applied to simultaneously monitor cerebral and renal rSO₂ from anaesthesia induction until the patient is transferred to the cardiac care unit. Serum S100 calcium-binding protein B (S100B) levels will be measured before CPB, at the end of the surgery and on postoperative day 1 to quantify cerebral injury. AKI will be diagnosed using the paediatric risk, injury, failure, loss, end-stage renal disease (pRIFLE) criteria based on dynamic creatinine changes. Health-related quality of life will be assessed through the paediatric quality of life (PedsQL) inventory at preoperative baseline and postoperative day 30.Ethics and dissemination This study has been approved by the Institutional Review Board of Beijing Children’s Hospital (approval number: [2024]-Y-093-D). Prior to enrolment, written informed consent will be obtained from the parents or legal guardians of all participating minors. The findings of this research will be disseminated through peer-reviewed publications and presentations at relevant conferences and shared with participating communities via lay summaries and social media platforms.Trial registration number The study was registered with the Chinese Clinical Trial Registry on 18 April 2024 (ChiCTR2400083225). |
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| ISSN: | 2044-6055 |