- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03957460
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
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
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Suwon, Korea, Republic of
- Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
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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.
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Subjects receive the continuous and noninvasive hemoglobin monitoring (SpHb monitoring).
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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
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SpHb value in g/dL is measured by co-oxymetry, and SaHb value in g/dL is measured by blood sampling.
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from the start of anesthesia to the end of anesthesia, an average 2 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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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