Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range

NCT03816514 | Completed

• 1 other identifier: H-1811-039-986
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemoglobins; Blood Transfusion; Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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)

  Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia

Secondary Outcomes (9)

• 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

• 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 intravenous fluids given

  Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia

Study Arms (2)

SpHb monitoring group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

SpHb monitoring PROCEDURE

Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring

SpHb monitoring group

Conventional management PROCEDURE

Conventional management without SpHb monitoring

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul national university hospital

Seoul, 110-744, South Korea

Location

Related Publications (4)

• 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.

  PMID: 21965372 BACKGROUND

• 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.

  PMID: 21545905 BACKGROUND

• 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.

  PMID: 25753142 BACKGROUND

• Park SK, Hur C, Kim YW, Yoo S, Lim YJ, Kim JT. Noninvasive hemoglobin monitoring for maintaining hemoglobin concentration within the target range during major noncardiac surgery: A randomized controlled trial. J Clin Anesth. 2024 May;93:111326. doi: 10.1016/j.jclinane.2023.111326. Epub 2023 Nov 20.

  PMID: 37988814 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin-Tae Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: January 25, 2019
• Study Start: March 4, 2019
• Primary Completion: November 2, 2020
• Study Completion: November 6, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

KR (1)