Pronto for Patient Blood Management

Anemia Clinical Trial

Official title:

Validation of Hb-measurement of Pronto ® as Screening Tool for Preoperative Diagnostic of Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586141
• Other study ID #: Pronto for PBM
• Status: Completed
• Phase: N/A
• Start date: July 22, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: February 2019
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1129
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• Written informed consent

Exclusion Criteria:

• no written informed consent

Related Conditions & MeSH terms

• Anemia

Intervention

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

Locations

Country	Name	City	State
Germany	Johannes Gutenbert University Centre	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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%.	five to ten minutes
Secondary	Validation of postulated non invasively measured haemoglobin value as a cut off-value 2	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%.	five to ten minutes
Secondary	Agreement between invasive and noninvasive measurement in adults and children	Noninvasive haemoglobin measurement values are compared with invasive haemoglobin measurement values	five to ten minutes