Effect of Prone Position on Continuous Noninvasive Hemoglobin Measurement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Refusal to participate in the study
ASA physical status IV-V
Hemoglobin level <10 g/dL
Presence of peripheral arterial disease
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Prone Positioning
Other interventionProne 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Patients Undergoing Lumbar Stabilization Surgery1 intervention
Trial outcomes
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.
Time frame
Intraoperative period, during supine and prone positioning on the day of surgerySecondary 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.
Time frame
Intraoperative period on the day of surgerySponsors and contacts
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Source ClinicalTrials.gov