Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range

Seoul National University

Status: Completed

Conditions: Hemorrhage; Blood Transfusion; Hemoglobins

Treatments: Procedure: Conventional management; Procedure: SpHb monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03816514

H-1811-039-986

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups

SpHb monitoring group

Experimental group

Description:

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.

Treatment:

Procedure: SpHb monitoring

Control group

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional management