Assessing the Accuracy of the RevK Sensor | NCT01877876

Studies
Assessing the Accuracy of the RevK Sensor

NCT01877876

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Jun 10, 2015Estimated

Enrollment

8Actual

Phase

Not provided

Conditions

Patients Undergoing Spine Surgery

Interventions

Not provided

Countries

United States

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

Jun 2015

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

Jun 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Jun 2015Actual

First Submitted Date

May 28, 2013

First Submission Date that Met QC Criteria

Jun 11, 2013

First Posted Date

Jun 14, 2013Estimated

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

Jun 8, 2015

Last Update Posted Date

Jun 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version is RevK.

Detailed Description

Evaluation of a new generation of sensors for monitoring blood hemoglobin with the Masimo non-invasive hemoglobin monitor. The newest sensor version is RevK.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

8Actual

Label	Type	Description	Intervention Names
Patient undergoing spine surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the accuracy of the RevK sensor for measuring blood hemoglobin compared to a laboratory-derived hemoglobin value.	Primary outcome is based on the difference between a value from the SpHb (Masimo SpHb™ continuous hemoglobin reading) minus tHb (laboratory hemoglobin determination).	Intermittently during spine surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or non-pregnant female
American Society of Anesthesiology Classification 1, 2 or 3
Scheduled to undergo spine or hip surgery

Exclusion Criteria:

Pregnant or nursing
Patients who in the study investigators clinical judgement would not be suitable for research

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing spine surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronald D Miller, MD, MS	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94143	United States