Back to resultsEffect of Arterial Cannulation on the Continuous and Non-invasive Hemoglobin Monitoring
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
arterila cannulation on same arm
arterila cannulation on different arm
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Laparoscopic gastrectomy under general anesthesia
Exclusion Criteria:
- atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Same group
Different group
Arm Description
arterial cannulation on same arm of continuous hemoglobin monitoring
arterial cannulation on different arm of continuous hemoglobin monitoring
Outcomes
Primary Outcome Measures
difference between SpHb value and SaHb value (SpHb - SaHb) in g/dL
SpHb value (g/dL) is measured by co-oxymetry, and SaHb value (g/dL) is measured by blood sampling.
Secondary Outcome Measures
Full Information
NCT ID
NCT03957486
First Posted
May 17, 2019
Last Updated
May 9, 2021
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03957486
Brief Title
Effect of Arterial Cannulation on the Continuous and Non-invasive Hemoglobin Monitoring
Official Title
Effect of Arterial Cannulation on the Continuous and Non-invasive Hemoglobin Monitoring for Laparoscopic Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
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 purpose of this study is to investigate the effect of arterial cannulation on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Same group
Arm Type
Experimental
Arm Description
arterial cannulation on same arm of continuous hemoglobin monitoring
Arm Title
Different group
Arm Type
Placebo Comparator
Arm Description
arterial cannulation on different arm of continuous hemoglobin monitoring
Intervention Type
Other
Intervention Name(s)
arterila cannulation on same arm
Intervention Description
arterila cannulation on same arm receiving continous hemoglobin monitoring
Intervention Type
Other
Intervention Name(s)
arterila cannulation on different arm
Intervention Description
arterila cannulation different arm receiving continous hemoglobin monitoring
Primary Outcome Measure Information:
Title
difference between SpHb value and SaHb value (SpHb - SaHb) in g/dL
Description
SpHb value (g/dL) is measured by co-oxymetry, and SaHb value (g/dL) is measured by blood sampling.
Time Frame
3 time points from the start of anesthesia to the end of anesthesia, an average 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Laparoscopic gastrectomy under general anesthesia
Exclusion Criteria:
atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
City
Suwon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Arterial Cannulation on the Continuous and Non-invasive Hemoglobin Monitoring
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