Accuracy of Continuous and Non-invasive Hemoglobin Monitoring

May 9, 2021 updated by: Ji Eun Kim, Ajou University School of Medicine

Accuracy of Continuous and Non-invasive Hemoglobin Monitoring During Laparoscopic Gastrectomy: Observational Study

The primary purpose of this observational study is to investigate the accuracy on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

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
      • Suwon, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients were scheduled for laparoscopic gastrectomy and recieved the SpHb monitoring during surgery.

Description

Inclusion Criteria:

  • laparoscopic gastrectomy under general anesthesia

Exclusion Criteria:

  • atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
continuous and noninvasive hemoglobin monitoring
Group receive the continuous and noninvasive hemoglobin monitoring during laparoscopic gastrectomy.
Other: SpHb monitoring
Subjects receive the continuous and noninvasive hemoglobin monitoring (SpHb monitoring).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference between SpHb value in g/dL and SaHb value in g/dL (SpHb - SaHb)
Time Frame: from the start of anesthesia to the end of anesthesia, an average 2 hours
SpHb value in g/dL is measured by co-oxymetry, and SaHb value in g/dL is measured by blood sampling.
from the start of anesthesia to the end of anesthesia, an average 2 hours

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

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)

November 20, 2017

Primary Completion (Actual)

December 29, 2017

Study Completion (Actual)

December 29, 2017

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

May 19, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 9, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-OBS-17-216

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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