Anemia
Conditions
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.
Interventions
DIAGNOSTIC_TESTPronto® hemoglobin measurement tool
All patients who are planned to undergo elective surgery come to the preoperative anesthetic ambulance. They are all measured by the Pronto® hemoglobin measurement tool
Sponsors
Johannes Gutenberg University Mainz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
measurement of hemoglobin by a noninvasive sensor clip
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Adults and children \>=3kg that are planned to undergo elective surgery * Written informed consent
Exclusion criteria
* no written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | five to ten minutes | Previous studies show that noninvasively measured haemoglobin is not accurate enough to determine exactly the haemoglobin value for preoperative diagnosis of anaemia. We postulate that noninvasive haemoglobin measurement can be used as a screening tool to decide wether invasive measurement of haemoglobin is necessary. We calculated a cut-off value 1 by analysing previous studies. Noninvasive haemoglobin measurements that are above the cut-off-value are postulated to show that the patient is not anaemic with a sensitivity of 99%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validation of postulated non invasively measured haemoglobin value as a cut off-value 2 | five to ten minutes | We calculated a cut-off value 2 by analysing previous studies. Noninvasive haemoglobin measurements that are below the cut-off-value 2 are postulated to show that the patient is anaemic with a speciality of 99%. |
| Agreement between invasive and noninvasive measurement in adults and children | five to ten minutes | Noninvasive haemoglobin measurement values are compared with invasive haemoglobin measurement values |
Countries
Germany
Outcome results
None listed