Evaluate the Accuracy of the NBM200 for Noninvasive Hemoglobin Measurements on Obstetric/Gynecological Patients

Evaluate the Accuracy of the NBM200 for Noninvasive Hemoglobin Measurements on Obstetric/Gynecological Patients.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01917851

Enrollment

300

Registered

2013-08-07

Start date

2011-04-30

Completion date

2013-12-31

Last updated

2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

Accurate, Hb, noninvasive measurement

Brief summary

The purpose of the study is to define the precision, accuracy and variability of the NBM-200 system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.

Detailed description

Each subject will be placed in a comfortable position in a temperature regulated room. Participants will have two consecutive non invasive (NBM) measurements taken which involves inserting the thumb into a ring shaped sensor. After each non invasive measurement the sensor will be removed. Each measurement takes approximately 85 seconds and involves the finger cuff inflating (to over systolic pressure) and deflating several times in quick successions in order to measure and calculate the Hb values. The two non invasive measurements will be performed using the same finger. After the NBM system testing is complete and recorded, the subject will have a venous (venipuncture) blood sample collected in order to provide two blood tests performed on two different models of routine automated CBC or Hb blood analyzers.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Female volunteers aged 18 years and over. * Any patient subject to CBC testing according to OBGYN standard care and clinical judgment.

Exclusion criteria

* Participants under the age of 18 years * Significant deformity, degenerative changes or edema of the thumb or index fingers * Localized infection, ulceration or skin breaks involving the fingers * Low peripheral body temperature (tissue perfusion) \<36.0˚C * Vascular disease or Raynaud's phenomenon affecting the fingers * Participants who are unable to give informed written consent

Design outcomes

Primary

Measure	Time frame
Compare the Hb values from the NBM200 series against the Hb from the lab blood analyser on obstetric/gynecological patients.	1 day

Outcome results