Lumbar Stabilization SurgeryNCT07823569
Effect of Prone Position on Continuous Noninvasive Hemoglobin Measurement
An observational study of Lumbar Stabilization Surgery and Noninvasive Hemoglobin Monitoring, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Stabilization Surgery, Noninvasive Hemoglobin Monitoring
- What is being tested?
- Prone Positioning
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Refusal to participate in the study
- ASA physical status IV-V
- Hemoglobin level <10 g/dL
- Presence of peripheral arterial disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul, Istanbul, 34000
Sule Altuncu, MD, 02166063300, sancaktepeetikkurul@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Prone Positioning
- Keywords
- Prone Position, Noninvasive Hemoglobin Monitoring, SpHb, Laboratory Hemoglobin, Pulse CO-Oximetry, Perioperative Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PositioningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Prone Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative period, during supine and prone positioning on the day of surgery
Secondary outcomes (1)
Ability of SpHb to Track Intraoperative Hemoglobin Changes
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.
Measured: Intraoperative period on the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start11 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lumbar Stabilization SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Altuncu, Principal investigator, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823569
- Sponsor's protocol ID
- PRONE-NIHb-2026-486
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31101083Berkow 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.
PubMed 21965372Park 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.
PubMed 37988814Adel 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.
PubMed 29335914Erdogan 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.
PubMed 28106356
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Prone Position Affect Continuous Noninvasive Hemoglobin Measurement?
- ClinicalTrials.gov ID
- NCT07823569
- Acronym / sponsor ID
- PRONE-NIHb-2026-486
- Keywords
- Prone Position, Noninvasive Hemoglobin Monitoring, SpHb, Laboratory Hemoglobin, Pulse CO-Oximetry, Perioperative Monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Lumbar Stabilization Surgery | – | Other: Prone PositioningAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- ASA physical status IV-V
- Hemoglobin level <10 g/dL
- Presence of peripheral arterial disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone PositioningProne 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. | Other | Patients Undergoing Lumbar Stabilization Surgery |
Primary outcome
Agreement Between Noninvasive Hemoglobin (SpHb) and Laboratory Hemoglobin Measurements
Time frame: 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.
1 secondary outcome
Ability of SpHb to Track Intraoperative Hemoglobin Changes
Time frame: Intraoperative period on the day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Results publication: PubMed 31101083Tang 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.
- Results publication: PubMed 21965372Berkow 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.
- Results publication: PubMed 37988814Park 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.
- Results publication: PubMed 29335914Adel 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.
- Results publication: PubMed 28106356Erdogan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Altuncu principal investigator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Stabilization Surgery and Noninvasive Hemoglobin Monitoring, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Şule Altuncu, MD (02166063300, sancaktepeetikkurul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Noninvasive Hemoglobin (SpHb) and Laboratory Hemoglobin Measurements (time frame: Intraoperative period, during supine and prone positioning on the day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07823569, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.