Pronto for Patient Blood Management

Overview

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.

Full Title of Study: “Validation of Hb-measurement of Pronto ® as Screening Tool for Preoperative Diagnostic of Anemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2018

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 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

Arms, Groups and Cohorts

  • Other: noninvasive measurement of hemoglobin
    • All participating patients are measured by the Pronto® hemoglobin measurement tool

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 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 Measures

  • Validation of postulated non invasively measured haemoglobin value as a cut off-value 2
    • Time Frame: 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
    • Time Frame: five to ten minutes
    • Noninvasive haemoglobin measurement values are compared with invasive haemoglobin measurement values

Participating in This Clinical Trial

Inclusion Criteria

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

  • no written informed consent

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johannes Gutenberg University Mainz
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Eva Wittenmeier, Principal Investigator – Johannes Gutenberg University Mainz
  • Overall Official(s)
    • Eva Wittenmeier, MD, Principal Investigator, Johannes Gutenberg University Centre, department of anaesthesiology, Langenbeckstraße 1, 55131 Mainz, Germany

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