Comparison of Three Methods of Hemoglobin Monitoring

Comparison of Three Methods of Hemoglobin Monitoring in Patients Undergoing Spine or Hip Surgery

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).

Study Overview

• Status: Completed
• Conditions: Digital Block
• Intervention / Treatment: Drug: Lidocaine digital block; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Ronald D Miller, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: January 19, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 26, 2011

Study Record Updates

• Last Update Posted (Estimate): May 28, 2012
• Last Update Submitted That Met QC Criteria: May 18, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Chrysarobin
• Other Study ID Numbers: 10-00524B