HemoglobinsNCT03816514
Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range
A study testing SpHb monitoring and Conventional management in people with Hemoglobins and Blood Transfusion, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hemoglobins, Blood Transfusion, Hemorrhage
- What is being tested?
- SpHb monitoring and Conventional management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Mar 2019to 6 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Use of Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range During Major Surgery: A Randomized Controlled Trial
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
- Being tested
- SpHb monitoring, Conventional management
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpHb monitoringProcedure or surgery
Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring
Conventional managementProcedure or surgery
Conventional management without SpHb monitoring
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
The percentage extent of deviation of laboratory hemoglobin out of the prespecified target range
Measured: 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
Number of Point-of-care (POC) sampling for measurement of hemoglobin concentration. In SpHb group, POC sampling will be done according to SpHb level. In control group, POC sampling will be done at discretion of anesthesiologist.
Measured: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Accuracy of the SpHb value
Standard Laboratory hemoglobin measurement will be used as reference. Laboratory measurements will be done every 30 minute during surgery
Measured: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Number of patients who receive intra-operative transfusion
Number of patients who were transfused with pRBCs intraoperatively
Measured: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Total volume of intravenous fluids given
Total volume of intravenous fluids given intra-operatively
Measured: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Total volume of pRBCs transfused
Total volume of pRBCs transfused intra-operatively
Measured: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Time for transfusion delay
Time from the determination of transfusion to actual transfusion, in minutes
Measured: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Incidence of intraoperative hypotension
hypotension is defined as SBP < 80% of baseline SBP
Measured: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
laboratory total hemoglobin value, at postoperative day 1
total hemoglobin value measured by standard laboratory method
Measured: at postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start4 Mar 2019
- Primary completion2 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemoglobinsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816514
- Sponsor's protocol ID
- H-1811-039-986
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2018
- Last updated
- 22 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21965372Causey 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.
PubMed 21545905Galvagno 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.
PubMed 25753142Park 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.
PubMed 37988814
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range During Major Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03816514
- Acronym / sponsor ID
- H-1811-039-986
- Conditions
- Hemoglobins, Blood Transfusion, Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SpHb monitoring group | Experimental | Procedure: SpHb monitoringIn 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. |
| Control group | Active comparator | Procedure: Conventional managementIn 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpHb monitoringNoninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring | Procedure or surgery | SpHb monitoring group |
| Conventional managementConventional management without SpHb monitoring | Procedure or surgery | Control group |
Primary outcome
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)
9 secondary outcomes
The percentage extent 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
Number of Point-of-care (POC) sampling during surgery
Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Accuracy of the SpHb value
Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Number of patients who receive intra-operative transfusion
Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Total volume of intravenous fluids given
Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Total volume of pRBCs transfused
Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Time for transfusion delay
Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Incidence of intraoperative hypotension
Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
laboratory total hemoglobin value, at postoperative day 1
Time frame: at postoperative day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Background: PubMed 21965372Berkow 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.
- Background: PubMed 21545905Causey 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.
- Background: PubMed 25753142Galvagno 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.
- Derived from this study: PubMed 37988814Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Tae Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpHb monitoring and Conventional management in people with Hemoglobins and Blood Transfusion, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03816514, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.