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

Seoul National University Hospital1 site in 1 country130 target enrollmentMarch 4, 2019

ConditionsHemoglobins Blood Transfusion Hemorrhage

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hemoglobins
Sponsor: Seoul National University Hospital
Enrollment: 130
Locations: 1
Primary Endpoint: The incidence of deviation from the target hemoglobin range
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 4, 2019

End Date

November 6, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jin-Tae Kim

Professor

Seoul National University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The incidence of deviation from the target hemoglobin range

Time Frame: 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 Outcomes

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)
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)
Total volume of intravenous fluids given(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
Accuracy of the SpHb value(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
Number of patients who receive intra-operative transfusion(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
Total volume of pRBCs transfused(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
Time for transfusion delay(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
Incidence of intraoperative hypotension(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
laboratory total hemoglobin value, at postoperative day 1(at postoperative day 1)