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The primary aim of this study is to evaluate whether pulse oximetry based noninvasive hemoglobin (SpHb) monitoring can reduce the incidence of hemoglobin (Hb) level out of the target range in adult patients undergoing major surgery with the potential risk of bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpHb monitoring group | Experimental | In SpHb monitoring group, noninvasive, continuous SpHb monitoring will be done using Radical-7 pulse CO-Oximeter. The patients will be managed according to the prespecified protocol based on the SpHb values. |
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| Control group | Active Comparator | In control group, patients will receive conventional management without the SpHb monitoring. In these patients, the information about hemoglobin concentration of the patients will be obtained from hemoglobin measurement analyzed by point-of-care (POC) equipment, as usual standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpHb monitoring | Procedure | Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of deviation from the target hemoglobin range | (The number of laboratory samples with the result hemoglobin concentrations were out of the target range)/(Total number of laboratory samples that performed during intra-operative periods) | Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage extent of deviation from the target hemoglobin range | The percentage extent of deviation of laboratory hemoglobin out of the prespecified target range | Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia |
| Number of Point-of-care (POC) sampling during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21965372 | Background | 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. | |
| 21545905 | Background | Causey MW, Miller S, Foster A, Beekley A, Zenger D, Martin M. Validation of noninvasive hemoglobin measurements using the Masimo Radical-7 SpHb Station. Am J Surg. 2011 May;201(5):592-8. doi: 10.1016/j.amjsurg.2011.01.020. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Conventional management | Procedure | Conventional management without SpHb monitoring |
|
Number of Point-of-care (POC) sampling for measurement of hemoglobin concentration. In SpHb group, POC sampling will be done according to SpHb level. In control group, POC sampling will be done at discretion of anesthesiologist. |
| Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia |
| Accuracy of the SpHb value | Standard Laboratory hemoglobin measurement will be used as reference. Laboratory measurements will be done every 30 minute during surgery | Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia |
| Number of patients who receive intra-operative transfusion | Number of patients who were transfused with pRBCs intraoperatively | Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia |
| Total volume of intravenous fluids given | Total volume of intravenous fluids given intra-operatively | Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia |
| Total volume of pRBCs transfused | Total volume of pRBCs transfused intra-operatively | Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia |
| Time for transfusion delay | Time from the determination of transfusion to actual transfusion, in minutes | Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia |
| Incidence of intraoperative hypotension | hypotension is defined as SBP < 80% of baseline SBP | Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia |
| laboratory total hemoglobin value, at postoperative day 1 | total hemoglobin value measured by standard laboratory method | at postoperative day 1 |
| 25753142 | Background | Galvagno SM Jr, Hu P, Yang S, Gao C, Hanna D, Shackelford S, Mackenzie C. Accuracy of continuous noninvasive hemoglobin monitoring for the prediction of blood transfusions in trauma patients. J Clin Monit Comput. 2015 Dec;29(6):815-21. doi: 10.1007/s10877-015-9671-1. Epub 2015 Mar 10. |
| 37988814 | Derived | 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. |