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NCT01992003 Clinical Trial

Butterfly Sensor With Rev K Version

Blood Loss Clinical Trial

Official title:
Assessing the Accuracy of the Butterfly Sensor With RevK Version for Non-Invasive Hemoglobin Monitoring

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01992003
Other study ID # 10-00524F
Secondary ID
Status Terminated
Phase Phase 4
First received November 18, 2013
Last updated April 8, 2015
Start date January 2014
Est. completion date December 2014

Study information
Verified date April 2015
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Human Research Protection Program
Study type Observational

Clinical Trial Summary

The primary purpose of this study is to assess the accuracy of the newly released Masimo SpHb Butterfly Sensor with RevK version and compare the results to a blood hemoglobin level analyzed in the UCSF Clinical Laboratories. A secondary purpose is to assess the blood hemoglobin using the Masimo Pronto-7 hand-held device immediately prior to surgery.

Description:

- Masimo SpHb™ continuous hemoglobin monitoring The Masimo SpHb™ monitor with the Butterfly Sensor with RevK version will be used to continuously monitor hemoglobin electronically. The Butterfly Sensor will be connected to the 3rd or 4th finger on either the right or left hand.

- Masimo Pronto-7™ intermittent hemoglobin monitoring The Masimo Pronto-7™ is a hand-held, noninvasive device used for intermittent measuring of blood hemoglobin. The device is connected to a re-usable sensor which is clipped onto a finger for quick spot-check readings. A reading from the Pronto-7 will be taken immediately before surgery.

- Blood sampling for hemoglobin determination For the study, about a ½ tsp of blood will be collected from the arterial line placed for the purpose of surgery approximately every hour during the surgery to obtain a hemoglobin measurement to be analyzed in the UCSF Clinical Lab.

Recruitment information / eligibility
Status Terminated
Enrollment 9
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male of non-pregnant female 18 y/o or older

- American Society of Anesthesiologists Classification 1,2 or 3

- Scheduled to undergo spine or hip surgery

Exclusion Criteria:

- Pregnant or nursing

- Patients who in the investigators clinical judgement would not be suitable for research

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary purpose of this study is to assess the accuracy of the newly released Masimo SpHb Butterfly Sensor with RevK version and compare the results to a blood hemoglobin level. During surgery No
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