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Comparison of Three Methods of Hemoglobin Monitoring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01284296
First received: January 19, 2011
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

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).


Condition Intervention
Digital Block
 Drug: Lidocaine digital block
Device: Masimo SpHb continuous hemoglobin monitor

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Comparison of Three Methods of Hemoglobin Monitoring in Patients Undergoing Spine or Hip Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block. [ Time Frame: A minimum of 2-4 differences recorded approximately hourly during surgery ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Digital block Drug: Lidocaine digital block
One dose of lidocaine 2% injected locally into one finger (2 mls total)
Device: Masimo SpHb continuous hemoglobin monitor
Masimo SpHb continuous hemoglobin monitor

Detailed Description:

We have completed a study with 20 patients using the latest version of the SpHb monitor software and finger sensor.

The purpose of this study is to assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb) following the digital block.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or nursing
  • Patients who in the study investigators clinical judgement would not be suitable for research.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284296

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Ronald D Miller, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01284296     History of Changes
Other Study ID Numbers: 10-00524B
Study First Received: January 19, 2011
Results First Received: April 3, 2012
Last Updated: May 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013