Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range

Study Overview
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Brief Summary
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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.

Official Title
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Use of Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range During Major Surgery: A Randomized Controlled Trial

Conditions
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Hemoglobins, Blood Transfusion, Hemorrhage

Intervention / Treatment
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* Procedure: SpHb monitoring
* Procedure: Conventional management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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 Patients who are requiring an arterial catheter as a part of their standard care. Exclusion Criteria: Patients with preexisting deformity or skin condition that would impede sensor placement Patients with allergies to the adhesive sensor material Patients with uncorrected preoperative anemia (preoperative hemoglobin < 7 g/dL) Patients who were not suitable for participation in the opinion of the study investigator.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpHb monitoring group<br>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<br>* Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring<br>|
| Active Comparator: Control group<br>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<br>* Conventional management without SpHb monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |