Clinical trial NCT03816514: Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range
Official title: Use of Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range During Major Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemoglobins
Blood Transfusion
Hemorrhage
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 130
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: The incidence of deviation from the target hemoglobin range
timeFrame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Secondary outcomes:
measure: The percentage extent of deviation from the target hemoglobin range
timeFrame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
measure: Number of Point-of-care (POC) sampling during surgery
timeFrame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
measure: Accuracy of the SpHb value
timeFrame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
measure: Number of patients who receive intra-operative transfusion
timeFrame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
measure: Total volume of intravenous fluids given
timeFrame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
measure: Total volume of pRBCs transfused
timeFrame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
measure: Time for transfusion delay
timeFrame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
measure: Incidence of intraoperative hypotension
timeFrame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
measure: laboratory total hemoglobin value, at postoperative day 1
timeFrame: at postoperative day 1
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berkow L, Rotolo S, Mirski E. Continuous noninvasive hemoglobin monitoring during complex spine surgery. Anesth Analg. 2011 Dec;113(6):1396-402. doi: 10.1213/ANE.0b013e318230b425. Epub 2011 Sep 29.
citation: Causey MW, Miller S, Foster A, Beekley A, Zenger D, Martin M. Validation of noninvasive hemoglobin measurements using the Masimo Radical-7 SpHb Station. Am J Surg. 2011 May;201(5):592-8. doi: 10.1016/j.amjsurg.2011.01.020.
citation: Galvagno SM Jr, Hu P, Yang S, Gao C, Hanna D, Shackelford S, Mackenzie C. Accuracy of continuous noninvasive hemoglobin monitoring for the prediction of blood transfusions in trauma patients. J Clin Monit Comput. 2015 Dec;29(6):815-21. doi: 10.1007/s10877-015-9671-1. Epub 2015 Mar 10.