MASIMO Radical 7 and Laboratory Measurement | NCT01706276

Studies
MASIMO Radical 7 and Laboratory Measurement

NCT01706276

Sponsor

Huazhong University of Science and Technology

Status

Completed

Last Update Posted

Nov 20, 2013Estimated

Enrollment

225Actual

Phase

Not provided

Conditions

Major Hepatic Surgery

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Oct 10, 2012

First Submission Date that Met QC Criteria

Oct 11, 2012

First Posted Date

Oct 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2013

Last Update Posted Date

Nov 20, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wei Mei, Associate Professor, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

225Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuke Tian, MD.	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology		Wuhan	Hubei	430030	China