MASIMO Radical 7 and Laboratory Measurement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01706276
First received: October 10, 2012
Last updated: November 19, 2013
Last verified: November 2013
  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 Huazhong University of Science and Technology:

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

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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wei Mei, Associate Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01706276     History of Changes
Other Study ID Numbers: TJMZK20120902
Study First Received: October 10, 2012
Last Updated: November 19, 2013
Health Authority: China: Ministry of Health

ClinicalTrials.gov processed this record on July 20, 2014