Clinical trial NCT01893645: Pronto-7: Accuracy of Non-invasive Hemoglobin Measurement in Parturients
Official title: Pronto-7: Accuracy of Non-invasive Hemoglobin Measurement in Parturients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemoglobin Levels in Blood
Keywords: Pronto-7
SpHb
Obstetric patients
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
First posted: 2013-07-09
Enrollment: 71
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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).

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.

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.

Eligibility 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

Primary outcomes:
measure: Hemoglobin (Hb) value
timeFrame: 15-20 minutes before venipuncture
Secondary outcomes:
measure: Comparisons of SpHb values
timeFrame: 15-20 minutes before venipuncture and 15-20 minutes after venipuncture
Other outcomes:
measure: Consistency of lab Hb results
timeFrame: 4 hours after venipuncture
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Vit Gunka, MD
role: PRINCIPAL_INVESTIGATOR
References:
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