Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Arterial Cannulation on the Continuous and Non-invasive Hemoglobin Monitoring
Official Title  ICMJE Effect of Arterial Cannulation on the Continuous and Non-invasive Hemoglobin Monitoring for Laparoscopic Gastrectomy
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Other: arterila cannulation on same arm
    arterila cannulation on same arm receiving continous hemoglobin monitoring
  • Other: arterila cannulation on different arm
    arterila cannulation different arm receiving continous hemoglobin monitoring
Study Arms  ICMJE
  • Experimental: Same group
    arterial cannulation on same arm of continuous hemoglobin monitoring
    Intervention: Other: arterila cannulation on same arm
  • Placebo Comparator: Different group
    arterial cannulation on different arm of continuous hemoglobin monitoring
    Intervention: Other: arterila cannulation on different arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2019)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Laparoscopic gastrectomy under general anesthesia

Exclusion Criteria:

  • atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957486
Other Study ID Numbers  ICMJE AJIRB-MED-OBS-18-48
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ji Eun Kim, Ajou University School of Medicine
Study Sponsor  ICMJE Ajou University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ajou University School of Medicine
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP