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Completed

NCT Number: NCT01893645

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

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.

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Key information

Age range

19 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Pronto-7

Device

A new point-of-care pulse co-oximeter that offers a non-invasive and quick spot-checking of Hb (SpHb).

Primary outcomes

  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 outcomes

  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 outcomes

  1. Consistency of lab Hb results

    Time frame: 4 hours after venipuncture

    Comparison between the first and second reading on the laboratory Cooximeter.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Masimo Corporation

Registry information

Acronym: Pronto-7

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 9, 2013
Registry last updated
Sep 30, 2014

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.