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MASIMO Radical 7 and Laboratory Measurement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01706276
First Posted: October 15, 2012
Last Update Posted: November 20, 2013
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology
  Purpose
Present study aimed to evaluate the accuracy of Masimo Radical 7 to monitor hemoglobin concentrations through compared with laboratory measurement during major hepatic surgery, and to determine the source of discordance between two methods.

Condition
Major Hepatic Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Further study details as provided by Wei Mei, Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Hemoglobin measurement using the Masimo device [ Time Frame: 0.5h after skin incision ]

Secondary Outcome Measures:
  • Change of Hemoglobin measurement using the Masimo device [ Time Frame: 1h and 3h after skin incision ]

Enrollment: 225
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients, American Society of Anesthesiologists Physical Status Ⅰor Ⅱ, scheduled for potentially hemorrhagic major hepatic resection under general anesthesia and requiring an arterial line
Criteria

Inclusion Criteria:

  • adult patients
  • American Society of Anesthesiologists Physical Status Ⅰor Ⅱ
  • scheduled for potentially hemorrhagic major hepatic resection under general anesthesia
  • requiring an arterial line

Exclusion Criteria:

  • coagulopathy
  • hemoglobinopathy
  • cardiac dysrhythmias
  • arrhythmia
  • intracardiac shunt
  • heart valve diseases
  • tinea unguium
  • arterio puncture failure
  Contacts and Locations
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): NCT01706276


Locations
China, Hubei
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Study Chair: Yuke Tian, MD. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  More Information

Responsible Party: Wei Mei, Associate Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01706276     History of Changes
Other Study ID Numbers: TJMZK20120902
First Submitted: October 10, 2012
First Posted: October 15, 2012
Last Update Posted: November 20, 2013
Last Verified: November 2013