Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SpHb monitoring group 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. |
Procedure: SpHb monitoring
Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring
|
| Active Comparator: Control group 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. |
Procedure: Conventional management
Conventional management without SpHb monitoring
|
Outcome Measures
Primary Outcome Measures
- The incidence of deviation from the target hemoglobin range [Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia]
(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)
Secondary Outcome Measures
- The percentage extent of deviation from the target hemoglobin range [Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia]
The percentage extent of deviation of laboratory hemoglobin out of the prespecified target range
- Number of Point-of-care (POC) sampling during surgery [Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia]
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.
- Accuracy of the SpHb value [Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia]
Standard Laboratory hemoglobin measurement will be used as reference. Laboratory measurements will be done every 30 minute during surgery
- Number of patients who receive intra-operative transfusion [Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia]
Number of patients who were transfused with pRBCs intraoperatively
- Total volume of intravenous fluids given [Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia]
Total volume of intravenous fluids given intra-operatively
- Total volume of pRBCs transfused [Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia]
Total volume of pRBCs transfused intra-operatively
- Time for transfusion delay [Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia]
Time from the determination of transfusion to actual transfusion, in minutes
- Incidence of intraoperative hypotension [Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia]
hypotension is defined as SBP < 80% of baseline SBP
- laboratory total hemoglobin value, at postoperative day 1 [at postoperative day 1]
total hemoglobin value measured by standard laboratory method
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients with ASA physical status class I, II, III, who scheduled to undergo elective non-cardiac major surgery with more than moderate risk of bleeding under general anesthesia or spinal anesthesia.
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Eligible Surgery include: Spine surgery, bone tumor surgery, Total Hip Replacement, ovarian cancer surgery, cervical cancer surgery, radical cystectomy, open retroperitoneal mass excision, Radical Retropubic Prostatectomy, explorative laparotomy for abdominal mass excision, abdominal aortic aneurysm repair
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Patients who are requiring an arterial catheter as a part of their standard care.
Exclusion Criteria:
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Patients with preexisting deformity or skin condition that would impede sensor placement
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Patients with allergies to the adhesive sensor material
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Patients with uncorrected preoperative anemia (preoperative hemoglobin < 7 g/dL)
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Patients who were not suitable for participation in the opinion of the study investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul national university hospital | Seoul | Korea, Republic of | 110-744 |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
- Principal Investigator: Jin-Tae Kim, MD, PhD, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- H-1811-039-986