NCT01284296

Brief Summary

This study will further investigate the Masimo SpHb \[FDA Approved\] continuous non-invasive hemoglobin monitor in spine surgery patients. (See NCT00792597) We will investigate the effect of enhanced circulation to the finger (which will be attached to the sensor) following a local injection (digital block) of lidocaine (an FDA approved local anesthetic), and assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
6 months until next milestone

Results Posted

Study results publicly available

April 4, 2012

Completed
Last Updated

May 28, 2012

Status Verified

May 1, 2012

Enrollment Period

1.2 years

First QC Date

January 19, 2011

Results QC Date

April 3, 2012

Last Update Submit

May 18, 2012

Conditions

Digital Block

Outcome Measures

Primary Outcomes (1)

  • Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block.

    A minimum of 2-4 differences recorded approximately hourly during surgery

Study Arms (1)

Digital block

EXPERIMENTAL
Drug: Lidocaine digital blockDevice: Masimo SpHb continuous hemoglobin monitor

Interventions

Lidocaine digital blockDRUG

One dose of lidocaine 2% injected locally into one finger (2 mls total)

Digital block
Masimo SpHb continuous hemoglobin monitorDEVICE

Masimo SpHb continuous hemoglobin monitor

Digital block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-pregnant female 18 y/o or older
  • ASA Classification 1, 2 or 3
  • Scheduled to undergo spine or hip revision surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Results Point of Contact

Title
Ronald D. Miller
Organization
University of California, San Francisco
millerr@anesthesia.ucsf.edu
415 476-9034

Study Officials

  • Ronald D Miller, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 26, 2011

Study Start

August 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

May 28, 2012

Results First Posted

April 4, 2012

Record last verified: 2012-05

Locations

US(1)