Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range
NCT ID: NCT03816514
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
130 participants
INTERVENTIONAL
2019-03-04
2020-11-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SpHb monitoring group
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.
SpHb monitoring
Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring
Control group
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.
Conventional management
Conventional management without SpHb monitoring
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SpHb monitoring
Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring
Conventional management
Conventional management without SpHb monitoring
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jin-Tae Kim
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jin-Tae Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul national university hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-1811-039-986
Identifier Type: -
Identifier Source: org_study_id