MASIMO Radical 7 and Laboratory Measurement

November 19, 2013 updated by: Wei Mei, Huazhong University of Science and Technology
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin measurement using the Masimo device
Time Frame: 0.5h after skin incision
0.5h after skin incision

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of Hemoglobin measurement using the Masimo device
Time Frame: 1h and 3h after skin incision
1h and 3h after skin incision

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Estimate)

November 20, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • TJMZK20120902

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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