Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range

December 20, 2020 updated by: Jin-Tae Kim, Seoul National University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: SpHb monitoring
Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring
Active Comparator: 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.
Procedure: Conventional management
Conventional management without SpHb monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2019

Primary Completion (Actual)

November 2, 2020

Study Completion (Actual)

November 6, 2020

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

January 23, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 20, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1811-039-986

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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