Validation in Baboon Model of Broadband NIR Monitoring for Neonate Gut Perfusion

新生儿肠道灌注宽带近红外监测狒狒模型的验证

• 批准号: 8321480
• 负责人: David A. Benaron
• 金额: $ 22.2万
• 依托单位: SPECTROS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8321480
• 关键词: Adult; Affect; Age; Autopsy; Blood; Blood Pressure; Blood Transfusion; Blood Vessels; Blood flow; Bolus Infusion; Brain; Cardiovascular system; Caring; Clinical Management; Critical Illness; Detection; Development; Devices; Disease; Doppler Ultrasound; Early identification; Ecchymosis; Enteral Feeding; Esophageal; Esophageal mucous membrane; Fatty acid glycerol esters; Feasibility Studies; Feces; Feeds; Functional disorder; Gestational Age; Growth; Heart; Heart Rate; Hemorrhage; Histologic; Histology; Hospital Costs; Hour; Human; Inflammation; Injury; Intervention; Intestines; Ischemia; Kidney; Life; Lung; Measurement; Measures; Metabolic acidosis; Methods; Modeling; Monitor; Morbidity - disease rate; Mucous Membrane; Necrotizing Enterocolitis; Neonatal Intensive Care; Neonatal Intensive Care Units; Normal Range; Oral mucous membrane structure; Organ; Outcome; Output; Oxygen; Oxygen saturation measurement; Papio; Patients; Penetration; Performance; Perfusion; Pharmaceutical Preparations; Physicians; Premature Infant; Pulse Oximetry; Reliance; Reporting; Respiratory physiology; Risk; Safety; Site; Source; Spectrum Analysis; Staging; Superior mesenteric artery structure; TStat; Techniques; Testing; Tissues; Transfusion; United States National Institutes of Health; Urine; Validation; Venous; Very Low Birth Weight Infant; Visible Radiation; Water; Weight; Work; animal tissue; design; feeding; heart function; heat injury; improved; innovation; mortality; neonatal human; neonate; novel; premature; rectal; response; safety testing; standard measure; tool; vasoconstriction

DESCRIPTION (provided by applicant): The bedside management of extremely pre-term neonates relies on the traditional methods of monitoring such as arterial blood pressure, heart rate, pulse oximetry, urine output and evidence of metabolic acidosis. However, these parameters may be delayed or misleading in the detection of poor tissue perfusion. Very frequently even though tissue perfusion may be inadequate, the arterial blood pressure may be in a normal range due to compensatory vasoconstriction. Despite their widespread use, no study has shown that use of these measures improves outcome, and reliance on these measures alone, may result in inappropriate cardiovascular intervention. Tissue spectroscopy can provide a more direct measure of the adequacy of oxygen delivery to tissue, by measuring local, venous-weighted, blood oxygen saturation, and is sensitive to local ischemia. Spectros introduced the first visible light spectroscopy oximeter, T-Stat, in 2006. The T-Stat achieves improved performance by using visible light as opposed to near-infrared (more commonly used in tissue oximetry), and by incorporating broadband spectroscopy (hundreds of wavelengths) to further improve accuracy of the measurement. Spectros is now extending this approach into the infrared with broadband visible/infrared oximetry, allowing for a number of substances to be reliably measured. Impaired intestinal function is a major source of morbidity and mortality in neonatal intensive care. Intestinal dysfunction is manifested by feeding intolerance, poor growth, malabsorbtion, and, in the severest cases, necrotizing enterocolitis (NEC). While NIRS oximetry devices have been applied somatically (renal, gut) in neonates, their inability to compensate for varying levels of fat, water and stool in the tissue has severely limited their utility as monitors of somatic perfusion. It is therefore desirable to develop a non-invasive somatic monitor using the visible/near-infrared portion of the spectrum that achieves the depth of penetration necessary for non-invasive somatic monitoring, but which also incorporates the broadband analysis techniques required to compensate for water, fat and stool that may be present. The impact of this study could be truly significant. This project is designed to study tissue perfusion as a marker for the early identification of circulatory compromise, providing early identification of patients at risk of somatic organ damage. Through the early identification of these patients, we anticipate perfusion targets can be developed to better manage feeding, transfusion, and use of inotropes to significantly improve outcome and reduce hospital costs for these patients. Aim 1 - To reduce to manufacturing a broadband Vis/NIR tissue oximeter for monitoring the oxygenation of the gut, prototyped in a just-completed NIH feasibility study, with values corrected for stool, fat, and water. Aim 2 - To determine the efficacy of the broadband oximeter to detect induced changes in tissue perfusion and intestinal blood flow in a premature baboon model for very low birth weight infants. Aim 3 - To determine the safety of probes used with the T-Stat Perfusion Monitor.

描述（由申请人提供）：极早产新生儿的床旁管理依赖于传统的监测方法，如动脉血压、心率、脉搏血氧饱和度、尿量和代谢性酸中毒的证据。然而，这些参数在检测组织灌注不良时可能会延迟或产生误导。很多时候，即使组织灌注可能不足，由于代偿性血管收缩，动脉血压也可能处于正常范围内。尽管它们被广泛使用，但没有研究表明使用这些措施可以改善结果，并且单独依赖这些措施可能会导致不适当的心血管干预。组织光谱可以通过测量局部静脉加权血氧饱和度来更直接地测量向组织输送氧气的充足性，并且对局部缺血敏感。 Spectros 于 2006 年推出了第一台可见光光谱血氧计 T-Stat。T-Stat 通过使用可见光而不是近红外光（更常用于组织血氧测定）并结合宽带光谱（数百个波长）以进一步提高测量精度。 Spectros 现在通过宽带可见光/红外血氧测定法将这种方法扩展到红外领域，从而可以可靠地测量多种物质。肠道功能受损是新生儿重症监护中发病和死亡的主要原因。肠道功能障碍表现为喂养不耐受、生长不良、吸收不良，最严重的情况下会出现坏死性小肠结肠炎 (NEC)。虽然 NIRS 血氧测定装置已应用于新生儿的体细胞（肾脏、肠道），但它们无法补偿组织中不同水平的脂肪、水和粪便，这严重限制了它们作为体细胞灌注监测器的用途。因此，需要开发一种使用光谱的可见/近红外部分的非侵入性体监测器，该监测器能够实现非侵入性体监测所需的穿透深度，同时还结合了补偿水所需的宽带分析技术。 、可能存在的脂肪和粪便。这项研究的影响可能确实非常重大。该项目旨在研究组织灌注作为早期识别循环障碍的标志物，从而早期识别有躯体器官损伤风险的患者。通过早期识别这些患者，我们预计可以制定灌注目标，以更好地管理喂养、输血和正性肌力药物的使用，从而显着改善这些患者的预后并降低住院费用。目标 1 - 减少制造用于监测肠道氧合的宽带可见光/近红外组织血氧计，该血氧计在刚刚完成的 NIH 可行性研究中原型化，并对粪便、脂肪和水的值进行了校正。目标 2 - 确定宽带血氧计检测极低出生体重婴儿早产狒狒模型中组织灌注和肠道血流诱导变化的功效。 目标 3 - 确定与 T-Stat 灌注监视器一起使用的探头的安全性。