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Completed

NCT Number: NCT01284296

Comparison of Three Methods of Hemoglobin Monitoring

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).

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Key information

Conditions

Digital Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine digital block

Drug

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

Masimo SpHb continuous hemoglobin monitor

Device

Masimo SpHb continuous hemoglobin monitor

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.

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 26, 2011
Registry last updated
May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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