Does the Prone Position Affect Continuous Noninvasive Hemoglobin Measurement?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Agreement Between Noninvasive Hemoglobin (SpHb) and Laboratory Hemoglobin Measurements
研究概览
简要总结
This prospective observational study aims to evaluate whether the prone position affects the agreement between noninvasive hemoglobin (SpHb) measurements and laboratory hemoglobin values in patients undergoing lumbar stabilization surgery under general anesthesia.
SpHb provides continuous, noninvasive monitoring of hemoglobin using multi-wavelength pulse CO-oximetry. However, its accuracy may be affected by changes in peripheral perfusion, hemodynamic status, and patient position. The prone position used during spine surgery may alter cardiovascular function and peripheral perfusion and may therefore influence SpHb measurements.
In this study, SpHb values obtained in the supine and prone positions will be compared with simultaneously obtained laboratory hemoglobin values. The study will also evaluate the ability of SpHb to follow changes in hemoglobin during surgery. The results may help clarify the clinical usefulness of continuous noninvasive hemoglobin monitoring during surgery performed in the prone position.
详细描述
This is a prospective, single-center observational study involving adult patients undergoing lumbar stabilization surgery under general anesthesia. Eligible patients will be older than 18 years and classified as American Society of Anesthesiologists (ASA) physical status I-III.
During surgery, noninvasive hemoglobin concentration (SpHb) will be monitored using a pulse CO-oximetry sensor placed on the finger as part of intraoperative monitoring. SpHb measurements will be compared with laboratory hemoglobin values obtained from blood gas analysis. Measurements obtained during supine and prone positioning will be evaluated to determine whether prone positioning affects the agreement between noninvasive and laboratory hemoglobin measurements.
Demographic and clinical characteristics, intraoperative hemodynamic variables, laboratory and blood gas parameters, estimated intraoperative blood loss, amount of transfused blood products, postoperative intensive care unit stay, and total hospital length of stay will also be recorded. The study will additionally assess the potential of SpHb for following intraoperative hemoglobin trends.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled to undergo lumbar stabilization surgery under general anesthesia
- •Provision of written informed consent for participation in the study
排除标准
- •Refusal to participate in the study
- •ASA physical status IV-V
- •Hemoglobin level <10 g/dL
- •Presence of peripheral arterial disease
研究组 & 干预措施
Patients Undergoing Lumbar Stabilization Surgery
Adult patients undergoing lumbar stabilization surgery under general anesthesia. Noninvasive hemoglobin (SpHb) and laboratory hemoglobin measurements will be obtained and compared during supine and prone positioning.
干预措施: Prone Positioning (Other)
结局指标
主要结局
Agreement Between Noninvasive Hemoglobin (SpHb) and Laboratory Hemoglobin Measurements
时间窗: Intraoperative period, during supine and prone positioning on the day of surgery
Paired noninvasive hemoglobin (SpHb) and laboratory hemoglobin values will be obtained at corresponding intraoperative time points in the supine and prone positions. The primary outcome is the agreement between SpHb and laboratory hemoglobin measurements and whether this agreement changes after positioning the patient prone.
次要结局
- Ability of SpHb to Track Intraoperative Hemoglobin Changes(Intraoperative period on the day of surgery)