Effect of Prone Position on Continuous Noninvasive Hemoglobin Measurement
Does the Prone Position Affect Continuous Noninvasive Hemoglobin Measurement?
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Sule Altuncu, MD
- 电话号码:02166063300
- 邮箱:sancaktepeetikkurul@gmail.com
学习地点
-
-
Istanbul
-
Istanbul、Istanbul、土耳其(türkiye)、34000
- 招聘中
- Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
-
接触:
- Sule Altuncu, MD
- 电话号码:02166063300
- 邮箱:sancaktepeetikkurul@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Refusal to participate in the study
- ASA physical status IV-V
- Hemoglobin level <10 g/dL
- Presence of peripheral arterial disease
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
Prone positioning is performed as part of standard surgical care for lumbar stabilization surgery and is not assigned by the investigators.
The study will evaluate the association between prone positioning and the agreement between noninvasive hemoglobin (SpHb) measurements and simultaneously obtained laboratory hemoglobin values.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Agreement Between Noninvasive Hemoglobin (SpHb) and Laboratory Hemoglobin Measurements
大体时间: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.
|
Intraoperative period, during supine and prone positioning on the day of surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ability of SpHb to Track Intraoperative Hemoglobin Changes
大体时间:Intraoperative period on the day of surgery
|
Changes in noninvasive hemoglobin (SpHb) measurements over the intraoperative period will be compared with corresponding changes in laboratory hemoglobin values to evaluate the ability of SpHb to track the direction and magnitude of hemoglobin changes during surgery.
|
Intraoperative period on the day of surgery
|
合作者和调查者
调查人员
- 首席研究员:Altuncu、Şehit Prof. Dr. İlhan Varank Sancaktepe Training and Research Hospital
出版物和有用的链接
一般刊物
- Tang B, Yu X, Xu L, Zhu A, Zhang Y, Huang Y. Continuous noninvasive hemoglobin monitoring estimates timing for detecting anemia better than clinicians: a randomized controlled trial. BMC Anesthesiol. 2019 May 17;19(1):80. doi: 10.1186/s12871-019-0755-1.
- Berkow L, Rotolo S, Mirski E. Continuous noninvasive hemoglobin monitoring during complex spine surgery. Anesth Analg. 2011 Dec;113(6):1396-402. doi: 10.1213/ANE.0b013e318230b425. Epub 2011 Sep 29.
- Park SK, Hur C, Kim YW, Yoo S, Lim YJ, Kim JT. Noninvasive hemoglobin monitoring for maintaining hemoglobin concentration within the target range during major noncardiac surgery: A randomized controlled trial. J Clin Anesth. 2024 May;93:111326. doi: 10.1016/j.jclinane.2023.111326. Epub 2023 Nov 20.
- Adel A, Awada W, Abdelhamid B, Omar H, Abd El Dayem O, Hasanin A, Rady A. Accuracy and trending of non-invasive hemoglobin measurement during different volume and perfusion statuses. J Clin Monit Comput. 2018 Dec;32(6):1025-1031. doi: 10.1007/s10877-018-0101-z. Epub 2018 Jan 15.
- Erdogan Kayhan G, Colak YZ, Sanli M, Ucar M, Toprak HI. Accuracy of non-invasive hemoglobin monitoring by pulse CO-oximeter during liver transplantation. Minerva Anestesiol. 2017 May;83(5):485-492. doi: 10.23736/S0375-9393.17.11652-4. Epub 2017 Jan 20.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PRONE-NIHb-2026-486
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.