Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range

Not Applicable

Completed

• Conditions: Hemorrhage; Hemoglobins; Blood Transfusion
• Interventions: Procedure: SpHb monitoring; Procedure: Conventional management

• Registration Number: NCT03816514
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-25
• Study Start: 2019-03-04
• Primary Completion: 2020-11-02
• Study Completion: 2020-11-06
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-20
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SpHb monitoring group	SpHb monitoring	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.
Control group	Conventional management	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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 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

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of