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Pronto-7: Accuracy of Non-invasive Hemoglobin Measurement in Parturients (Pronto-7)

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: NCT01893645
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : September 30, 2014
Sponsor:
Collaborator:
Masimo Corporation
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:

The measurement of blood hemoglobin (Hb) concentration is a routine procedure in pregnant women. The assessment of Hb involves several steps, including a needle stick, blood collection, blood sample analysis in the laboratory, and waiting for the results.

Pronto-7 (manufactured by Masimo, CA, USA) is a new portable device that allows a quick bedside Hb spot check. A finger clip probe, similar to the standard oxygen finger clip probe, provides hemoglobin values in less than 60 seconds.

In this prospective observational study the investigators will assess the clinical accuracy of Pronto-7 derived Hb values compared to the gold standard laboratory Hb values in obstetric patients. We will be calculating the mean difference between Pronto-7 and laboratory Hb values. We plan to recruit 55 pregnant women admitted for vaginal or cesarean delivery at BC Women's Hospital.


Condition or disease Intervention/treatment
Hemoglobin Levels in Blood Device: Pronto-7

Detailed Description:

Serum hemoglobin (Hb) concentration is one of the most common laboratory tests measured when a pregnant woman (parturient) is admitted for a vaginal or cesarean delivery. The Hb concentration is normally measured from a venous blood sample in clinical laboratories using co-oximetry.

A new point-of-care pulse co-oximeter, the Pronto-7 (Masimo Corporation, Irvine, CA, USA), is a portable device that offers a non-invasive and quick spot-checking of Hb (SpHb). Measurement with the Pronto-7 takes about 60 seconds and does not require the transfer of blood samples to a laboratory. In addition to SpHb, the device provides a perfusion index (PI) value (a numeric estimation of the pulse strength at the measurement site), heart rate, oxygen saturation, and finger temperature. Potential advantages of the Pronto-7 include reduced staff work, decreased exposure to potential biohazards, and reduced pain and discomfort to the patient.

A similar technology is used in Radical-7 pulse co-oximeter (Masimo Corporation, Irvine, CA, USA) for non-invasive Hb measurement. Radical-7 has been evaluated in human volunteers undergoing hemodilution, in patients undergoing spine surgeries, major urological procedures, and in critically ill patients. However, the results regarding the accuracy of this technology are conflicting.

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Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pronto-7: Accuracy of Non-invasive Hemoglobin Measurement in Parturients
Study Start Date : June 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Group/Cohort Intervention/treatment
Pregnant women
Pregnant women admitted to the British Columbia Women's Hospital for vaginal or cesarean delivery will get their Hb values spot-checked using the Pronto-7 device.
Device: Pronto-7
A new point-of-care pulse co-oximeter that offers a non-invasive and quick spot-checking of Hb (SpHb).




Primary Outcome Measures :
  1. Hemoglobin (Hb) value [ Time Frame: 15-20 minutes before venipuncture ]
    Difference between the pre-venipuncture SpHb values and the laboratory Hb values (SpHb-Lab Hb difference) measured from the same extremity of each subject


Secondary Outcome Measures :
  1. Comparisons of SpHb values [ Time Frame: 15-20 minutes before venipuncture and 15-20 minutes after venipuncture ]

    Comparison between right and left hand SpHb values measured immediately before venipuncture.

    Comparison between right and left hand SpHb values measured immediately after venipuncture.

    Comparison of SpHb values measured from the same extremity immediately before and after venipuncture.

    Comparison of the SpHb-lab Hb differences between subjects in labour for vaginal delivery and subjects undergoing elective cesarean delivery.



Other Outcome Measures:
  1. Consistency of lab Hb results [ Time Frame: 4 hours after venipuncture ]
    Comparison between the first and second reading on the laboratory Cooximeter.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women admitted to the British Columbia Women's Hospital for vaginal or cesarean delivery (either elective or emergency).
Criteria

Inclusion Criteria:

  • Are 19 - 40 years old
  • Understand written and oral English
  • Are greater than 37 weeks gestational age
  • Have a singleton pregnancy

Exclusion Criteria:

  • Have a laboratory Hb less than 100 g/L
  • Have abnormal Hb disorders
  • Have hyperbilirubinemia
  • Have a peripheral vascular disease (e.g. Reynaud's syndrome)
  • Have long or acrylic nails

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893645


Locations
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Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Masimo Corporation
Investigators
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Principal Investigator: Vit Gunka, MD University of British Columbia

Publications:

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01893645    
Other Study ID Numbers: H12-00755
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014
Keywords provided by University of British Columbia:
Pronto-7
SpHb
Obstetric patients