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Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range

Primary Purpose

Hemoglobins, Blood Transfusion, Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SpHb monitoring
Conventional management
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemoglobins

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul national university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SpHb monitoring group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

The percentage extent of deviation from the target hemoglobin range
The percentage extent of deviation of laboratory hemoglobin out of the prespecified target range
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.
Accuracy of the SpHb value
Standard Laboratory hemoglobin measurement will be used as reference. Laboratory measurements will be done every 30 minute during surgery
Number of patients who receive intra-operative transfusion
Number of patients who were transfused with pRBCs intraoperatively
Total volume of intravenous fluids given
Total volume of intravenous fluids given intra-operatively
Total volume of pRBCs transfused
Total volume of pRBCs transfused intra-operatively
Time for transfusion delay
Time from the determination of transfusion to actual transfusion, in minutes
Incidence of intraoperative hypotension
hypotension is defined as SBP < 80% of baseline SBP
laboratory total hemoglobin value, at postoperative day 1
total hemoglobin value measured by standard laboratory method

Full Information

First Posted
December 17, 2018
Last Updated
December 20, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03816514
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
November 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemoglobins, Blood Transfusion, Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SpHb monitoring group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
SpHb monitoring
Intervention Description
Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring
Intervention Type
Procedure
Intervention Name(s)
Conventional management
Intervention Description
Conventional management without SpHb monitoring
Primary Outcome Measure Information:
Title
The incidence of deviation from the target hemoglobin range
Description
(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)
Time Frame
Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Secondary Outcome Measure Information:
Title
The percentage extent of deviation from the target hemoglobin range
Description
The percentage extent of deviation of laboratory hemoglobin out of the prespecified target range
Time Frame
Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Title
Number of Point-of-care (POC) sampling during surgery
Description
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.
Time Frame
Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Title
Accuracy of the SpHb value
Description
Standard Laboratory hemoglobin measurement will be used as reference. Laboratory measurements will be done every 30 minute during surgery
Time Frame
Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Title
Number of patients who receive intra-operative transfusion
Description
Number of patients who were transfused with pRBCs intraoperatively
Time Frame
Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Title
Total volume of intravenous fluids given
Description
Total volume of intravenous fluids given intra-operatively
Time Frame
Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Title
Total volume of pRBCs transfused
Description
Total volume of pRBCs transfused intra-operatively
Time Frame
Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Title
Time for transfusion delay
Description
Time from the determination of transfusion to actual transfusion, in minutes
Time Frame
Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Title
Incidence of intraoperative hypotension
Description
hypotension is defined as SBP < 80% of baseline SBP
Time Frame
Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Title
laboratory total hemoglobin value, at postoperative day 1
Description
total hemoglobin value measured by standard laboratory method
Time Frame
at postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul national university hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21965372
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.
Results Reference
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PubMed Identifier
21545905
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.
Results Reference
background
PubMed Identifier
25753142
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.
Results Reference
background

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Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range

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