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Pronto for Patient Blood Management

J

Johannes Gutenberg University (JGU)

Status

Completed

Conditions

Anemia

Treatments

Diagnostic Test: Pronto® hemoglobin measurement tool

Study type

Interventional

Funder types

Other

Identifiers

NCT03586141
Pronto for PBM

Details and patient eligibility

About

The concept of Patient Blood Management requires preoperative diagnostic of anemia. To avoid the harmful procedure of venous puncture for drawing a blood sample, noninvasive measurement of hemoglobin has been developed. However noninvasive measurement of hemoglobin has yet been not accurate enough to replace invasive hemoglobin measurement. This study investigates if a noninvasive measurement tool can serve as a screening tool to find out for which patients invasive measurement of hemoglobin is necessary.

Full description

The noninvasive hemoglobin measurement tool Pronto® can measure hemoglobin noninvasively by a sensor clip. The investigators analyzed previous studies with the Pronto device and calculated two cut-off values of the noninvasive hemoglobin device. If noninvasive hemoglobin values are higher than cut off value 1 the investigators postulate that with a sensitivity of 99% the participant has no anemia. To confirm this, participants who are supposed to undergo elective surgery and come to the preoperative anesthetic ambulance are measured by the Pronto-device. The noninvasive measurements are compared with the laboratory values of the patients and cut-off value 1 can be confirmed.

Enrollment

1,129 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults and children >=3kg that are planned to undergo elective surgery
  • Written informed consent

Exclusion criteria

  • no written informed consent

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,129 participants in 1 patient group

noninvasive measurement of hemoglobin
Other group
Description:
All participating patients are measured by the Pronto® hemoglobin measurement tool
Treatment:
Diagnostic Test: Pronto® hemoglobin measurement tool

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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