Trials / Completed
CompletedNCT03586141
Pronto for Patient Blood Management
Validation of Hb-measurement of Pronto ® as Screening Tool for Preoperative Diagnostic of Anemia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,129 (actual)
- Sponsor
- Johannes Gutenberg University Mainz · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Pronto® 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 |
Timeline
- Start date
- 2018-07-22
- Primary completion
- 2018-11-30
- Completion
- 2018-11-30
- First posted
- 2018-07-13
- Last updated
- 2019-02-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03586141. Inclusion in this directory is not an endorsement.