Comparison of Three Methods of Hemoglobin Monitoring

Not Applicable

Completed

• Conditions: Digital Block
• Interventions: Drug: Lidocaine digital block; Device: Masimo SpHb continuous hemoglobin monitor

• Registration Number: NCT01284296
• Lead Sponsor: University of California, San Francisco

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).

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2012-04-03
• Results First Submitted QC: 2012-04-03
• Results First Posted: 2012-04-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-18
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital block	Lidocaine digital block	-
Digital block	Masimo SpHb continuous hemoglobin monitor	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States