Clinical trial NCT03586141: Pronto for Patient Blood Management
Official title: Validation of Hb-measurement of Pronto ® as Screening Tool for Preoperative Diagnostic of Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 1129
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: measurement of hemoglobin by a noninvasive sensor clip
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* no written informed consent

Primary outcomes:
measure: Validation of a postulated noninvasively measured haemoglobin value as a cut-off value for the decision wether invasively measuring of haemoglobin concentration for preoperative patient blood management is necessary.
timeFrame: five to ten minutes
Secondary outcomes:
measure: Validation of postulated non invasively measured haemoglobin value as a cut off-value 2
timeFrame: five to ten minutes
measure: Agreement between invasive and noninvasive measurement in adults and children
timeFrame: five to ten minutes
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Johannes Gutenbert University Centre
Study officials:
affiliation: Johannes Gutenberg University Centre, department of anaesthesiology, Langenbeckstraße 1, 55131 Mainz, Germany
name: Eva Wittenmeier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wittenmeier E, Paumen Y, Mildenberger P, Smetiprach J, Pirlich N, Griemert EV, Kriege M, Engelhard K. Non-invasive haemoglobin measurement as an index test to detect pre-operative anaemia in elective surgery patients - a prospective study. Anaesthesia. 2021 May;76(5):647-654. doi: 10.1111/anae.15312. Epub 2020 Nov 23.