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Comparison of Noninvasive Hemoglobin Disposable Sensors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03125031
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : June 6, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Tracking Information
First Submitted Date  ICMJE April 14, 2017
First Posted Date  ICMJE April 24, 2017
Results First Submitted Date  ICMJE May 8, 2017
Results First Posted Date  ICMJE June 6, 2017
Last Update Posted Date July 27, 2017
Actual Study Start Date  ICMJE July 10, 2014
Actual Primary Completion Date July 25, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
Accuracy of Noninvasive Sensors by Arms Calculation [ Time Frame: 1-5 hours ]
Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. The accuracy results from both sensors will be assessed for equivalence
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
SpHb Accuracy of Noninvasive Sensors (Rainbow Disposable Butterfly and Rainbow Disposable L) [ Time Frame: 1-5 hours ]
Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.
Change History Complete list of historical versions of study NCT03125031 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Noninvasive Hemoglobin Disposable Sensors
Official Title  ICMJE Not Provided
Brief Summary In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Device: Rainbow adhesive adult/pediatric sensor
  • Device: Rainbow adhesive adult/neonatal sensor
Study Arms  ICMJE
  • Experimental: Group- Sensor 1
    All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.
    Intervention: Device: Rainbow adhesive adult/pediatric sensor
  • Experimental: Group- Sensor 2
    All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
    Intervention: Device: Rainbow adhesive adult/neonatal sensor
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2017)
44
Original Actual Enrollment  ICMJE
 (submitted: April 20, 2017)
80
Actual Study Completion Date  ICMJE July 25, 2014
Actual Primary Completion Date July 25, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female
  • 18-40 years of age
  • Weight of at least 110 lbs and less than 250 lbs for subjects under 6 feet tall.
  • Physical status of ASA I of II
  • Able to read and communicate in English
  • Has signed written informed consent
  • Female, non pregnant.

Exclusion Criteria:

  • Age less than 18 yrs and greater than 40 years
  • If the Warming and cooling subjects have open cuts of skin abrasions on their extremities they will be excluded because alcohol spray may be painful.
  • Weight of less than 110 lbs or more than 250 lbs if the subject is less than 6 feet tall.
  • Hemoglobin less than 11 g/dL
  • ASA physical status of III. IV, V.
  • Pregnant
  • Subject has known drug or alcohol abuse
  • Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
  • Subject has experienced a head injury with loss of consciousness within the last year.
  • Subject has known neurological and psychiatric disorder that interferes with the subjects' level of consciousness.
  • Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, Lithum, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
  • Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Reynauds Syndrome.
  • Systolic BP >140 mmHg or Diastolic BP > 100 mmHg.
  • Baseline heart rate < 50 bpm.
  • Inability to tolerate sitting still or minimal movement for up to 90 minutes
  • Discretion of investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03125031
Other Study ID Numbers  ICMJE TR26947-TP16847A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masimo Corporation
Study Sponsor  ICMJE Masimo Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Masimo Corporation
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP