Effect of Prone Position on Continuous Noninvasive Hemoglobin Measurement

NCT07823569 | Recruiting

• 1 other identifier: PRONE-NIHb-2026-486
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Stabilization Surgery; Noninvasive Hemoglobin Monitoring

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Agreement Between Noninvasive Hemoglobin (SpHb) and Laboratory Hemoglobin Measurements

  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

Secondary Outcomes (1)

• Ability of SpHb to Track Intraoperative Hemoglobin Changes

  Intraoperative period on the day of surgery

Study Arms (1)

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.

Other: Prone Positioning

Interventions

Prone Positioning OTHER

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.

Patients Undergoing Lumbar Stabilization Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective lumbar stabilization surgery under general anesthesia at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital. Eligible participants will have an ASA physical status of I-III and will undergo intraoperative noninvasive hemoglobin (SpHb) monitoring together with laboratory hemoglobin measurements.

You may qualify if:

• 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

You may not qualify if:

• Refusal to participate in the study
• ASA physical status IV-V
• Hemoglobin level \<10 g/dL
• Presence of peripheral arterial disease

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

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

Istanbul, Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 31101083 RESULT

• 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.

  PMID: 21965372 RESULT

• 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.

  PMID: 37988814 RESULT

• 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.

  PMID: 29335914 RESULT

• 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.

  PMID: 28106356 RESULT

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Altuncu

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Şule Altuncu, MD

CONTACT

02166063300; sancaktepeetikkurul@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start: September 11, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)