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Butterfly Sensor With Rev K Version

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ClinicalTrials.gov Identifier: NCT01992003
Recruitment Status : Terminated (Interim analysis indicated accuracy unchanged from previous versions)
First Posted : November 25, 2013
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date November 18, 2013
First Posted Date November 25, 2013
Last Update Posted Date April 9, 2015
Study Start Date January 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 21, 2013)
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. [ Time Frame: During surgery ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Butterfly Sensor With Rev K Version
Official Title Assessing the Accuracy of the Butterfly Sensor With RevK Version for Non-Invasive Hemoglobin Monitoring
Brief 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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing spine surgery
Condition Blood Loss
Intervention Not Provided
Study Groups/Cohorts Patients undergoing spine surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: April 8, 2015)
9
Original Estimated Enrollment
 (submitted: November 21, 2013)
20
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01992003
Other Study ID Numbers 10-00524F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators
Principal Investigator: Ronald D Miller, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date April 2015