Pronto for Patient Blood Management

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Diagnostic test: Pronto® hemoglobin measurement tool

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 Type: Interventional
• Enrollment (Actual): 1129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55131
    • Johannes Gutenbert University Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• no written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: noninvasive measurement of hemoglobin; All participating patients are measured by the Pronto® hemoglobin measurement tool	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Eva Wittenmeier, MD, Johannes Gutenberg University Centre, department of anaesthesiology, Langenbeckstraße 1, 55131 Mainz, Germany

Publications and helpful links

General Publications

• Wittenmeier E, Paumen Y, Mildenberger P, Smetiprach J, Pirlich N, Griemert EV, Kriege M, Engelhard K. Non-invasive haemoglobin measurement as an index test to detect pre-operative anaemia in elective surgery patients - a prospective study. Anaesthesia. 2021 May;76(5):647-654. doi: 10.1111/anae.15312. Epub 2020 Nov 23.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 17, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: Pronto for PBM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No