Pronto for Patient Blood Management

Not Applicable

Completed

• Conditions: Anemia
• Interventions: Diagnostic Test: Pronto® hemoglobin measurement tool

• Registration Number: NCT03586141
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Study Timeline

• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-13
• Study Start: 2018-07-22
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-17
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1129

Inclusion Criteria

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

Exclusion Criteria

• no written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
noninvasive measurement of hemoglobin	Pronto® hemoglobin measurement tool	All participating patients are measured by the Pronto® hemoglobin measurement tool

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Johannes Gutenbert University Centre; 🇩🇪 Mainz, Germany