Prospective Observational Data Collection Study for Validation of a Near-Infrared Spectroscopy-Based Blood Hemoglobin Algorithm in Pediatric Patients Undergoing Cardiac Surgery or Cardiac Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Agreement Between Noninvasive and Invasive Hemoglobin Measurements
研究概览
简要总结
This study will enroll children and young adults who are scheduled to undergo planned heart surgery or a heart catheterization procedure while under general anesthesia. Researchers will collect information from a forehead sensor that measures oxygen levels in the body's tissues, along with blood hemoglobin measurements obtained from blood samples that are already being collected as part of routine medical care.
The goal of the study is to determine whether a blood hemoglobin monitoring method that has already been cleared by the U.S. Food and Drug Administration (FDA) for use in adults may also work well in pediatric patients.
详细描述
Background:
Continuous monitoring of blood hemoglobin levels may help clinicians identify changes in a patient's blood status during surgery and support decisions regarding blood transfusion. A noninvasive blood hemoglobin monitoring method has been developed using near-infrared spectroscopy (NIRS) technology incorporated into the ForeSight Tissue Oximetry System. This technology uses near-infrared light to measure tissue oxygenation and derive information related to blood hemoglobin levels. An algorithm based on these measurements has been validated and cleared by the U.S. Food and Drug Administration (FDA) for use in adult patients.
Study Purpose:
The purpose of this study is to collect synchronized physiologic and laboratory data from pediatric patients to evaluate the feasibility and performance of applying an FDA-cleared adult blood hemoglobin algorithm to pediatric populations. The study will compare hemoglobin values estimated by the algorithm with reference hemoglobin values measured from arterial blood samples using standard blood-gas/co-oximetry analysis.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age less than 21 years at the time of enrollment.
- •Scheduled for elective cardiac surgery or elective cardiac catheterization under general anesthesia.
- •Placement of an arterial catheter as part of routine clinical care for the procedure.
排除标准
- •Presence of skin, scalp, or craniofacial abnormalities that prevent proper placement of the near-infrared spectroscopy (NIRS) sensor or may significantly affect measurement quality.
- •Inability to obtain arterial blood hemoglobin measurements using standard clinical methods.
研究组 & 干预措施
Pediatric Cardiac Surgery and Pediatric Catheterization Patients
This cohort includes pediatric patients undergoing elective cardiac surgery or elective cardiac catheterization under general anesthesia. All participants receive standard clinical care, including routine physiologic monitoring and arterial blood sampling when clinically indicated.
As part of routine monitoring, a FDA-cleared near-infrared spectroscopy (NIRS)-based tissue oximetry system (ForeSight Tissue Oximetry System) will be placed on the forehead to continuously record cerebral tissue oxygenation during the procedure.
Arterial blood samples obtained for clinical care will be analyzed using standard blood-gas/co-oximetry methods to measure blood hemoglobin levels. In select cases, a small number of additional blood samples may be collected to support data analysis.
This is an observational study only. No investigational devices are used, no interventions are assigned, and there is no change to clinical management. All collected data are de-identified prior to analysis.
干预措施: Noninvasive hemoglobin monitoring (Device)
结局指标
主要结局
Agreement Between Noninvasive and Invasive Hemoglobin Measurements
时间窗: Intraoperative period (from induction of general anesthesia until end of procedure)
The primary outcome measure is the agreement between NIRS-estimated hemoglobin and hemoglobin measured from arterial blood samples. Both assessments measure hemoglobin concentration and will be reported in grams per deciliter (g/dL). Agreement will be assessed by comparing paired hemoglobin measurements from the two methods. The reported outcome will include the mean difference between the two measurements (g/dL) and the range of differences observed (g/dL).
次要结局
未报告次要终点
研究者
Dima Daaboul
Cardiac Anesthesiologist
Boston Children's Hospital