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Effect of Arterial Cannulation on the Continuous and Non-invasive Hemoglobin Monitoring

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ClinicalTrials.gov Identifier: NCT03957486
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ji Eun Kim, Ajou University School of Medicine

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Other: arterila cannulation on same arm Other: arterila cannulation on different arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Arterial Cannulation on the Continuous and Non-invasive Hemoglobin Monitoring for Laparoscopic Gastrectomy
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Same group
arterial cannulation on same arm of continuous hemoglobin monitoring
Other: arterila cannulation on same arm
arterila cannulation on same arm receiving continous hemoglobin monitoring

Placebo Comparator: Different group
arterial cannulation on different arm of continuous hemoglobin monitoring
Other: arterila cannulation on different arm
arterila cannulation different arm receiving continous hemoglobin monitoring




Primary Outcome Measures :
  1. difference between SpHb value and SaHb value (SpHb - SaHb) in g/dL [ Time Frame: 3 time points from the start of anesthesia to the end of anesthesia, an average 2 hours ]
    SpHb value (g/dL) is measured by co-oxymetry, and SaHb value (g/dL) is measured by blood sampling.



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Laparoscopic gastrectomy under general anesthesia

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957486


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine Recruiting
Suwon, Korea, Republic of
Contact: Ji Eun Kim    82-31-219-5575    beye98@aumc.ac.kr   
Sponsors and Collaborators
Ajou University School of Medicine

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Responsible Party: Ji Eun Kim, Assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03957486     History of Changes
Other Study ID Numbers: AJIRB-MED-OBS-18-48
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases