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Effect of Prone Position on Continuous Noninvasive Hemoglobin Measurement

Does the Prone Position Affect Continuous Noninvasive Hemoglobin Measurement?

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07823569
Enrollment
80
Registered
2026-09-16
Start date
2026-09-11
Completion date
2026-12-31
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Stabilization Surgery, Noninvasive Hemoglobin Monitoring

Keywords

Prone Position, Noninvasive Hemoglobin Monitoring, SpHb, Laboratory Hemoglobin, Pulse CO-Oximetry, Perioperative Monitoring

Brief summary

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.

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.

Interventions

OTHERProne 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.

Sponsors

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Agreement Between Noninvasive Hemoglobin (SpHb) and Laboratory Hemoglobin MeasurementsIntraoperative period, during supine and prone positioning on the day of surgeryPaired 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.

Secondary

MeasureTime frameDescription
Ability of SpHb to Track Intraoperative Hemoglobin ChangesIntraoperative period on the day of surgeryChanges 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTŞule Altuncu, MD
sancaktepeetikkurul@gmail.com02166063300
PRINCIPAL_INVESTIGATORAltuncu

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026