Comparison of Three Methods of Hemoglobin Monitoring

NCT ID: NCT01284296

Last Updated: 2012-05-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Digital Block

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Digital block

Group Type EXPERIMENTAL

Lidocaine digital block

Intervention Type DRUG

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

Masimo SpHb continuous hemoglobin monitor

Intervention Type DEVICE

Masimo SpHb continuous hemoglobin monitor

Interventions

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Lidocaine digital block

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

Intervention Type DRUG

Masimo SpHb continuous hemoglobin monitor

Masimo SpHb continuous hemoglobin monitor

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald D Miller, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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10-00524B

Identifier Type: -

Identifier Source: org_study_id

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