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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sule Altuncu, MD
- Phone Number: 02166063300
- Email: sancaktepeetikkurul@gmail.com
Study Locations
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34000
- Recruiting
- Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
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Contact:
- Sule Altuncu, MD
- Phone Number: 02166063300
- Email: sancaktepeetikkurul@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Agreement Between Noninvasive Hemoglobin (SpHb) and Laboratory Hemoglobin Measurements
Time Frame: Intraoperative period, during supine and prone positioning on the day of surgery
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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.
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Intraoperative period, during supine and prone positioning on the day of surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ability of SpHb to Track Intraoperative Hemoglobin Changes
Time Frame: Intraoperative period on the day of surgery
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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.
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Intraoperative period on the day of surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Altuncu, Şehit Prof. Dr. İlhan Varank Sancaktepe Training and Research Hospital
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRONE-NIHb-2026-486
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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