An interventional study of SpHb monitoring and Conventional management in Hemoglobins, Blood Transfusion and Hemorrhage, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-12-22.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 130 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring
Conventional management without SpHb monitoring
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)
Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
The percentage extent of deviation from the target hemoglobin range
The percentage extent of deviation of laboratory hemoglobin out of the prespecified target range
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at postoperative day 1
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital