Pronto for Patient Blood Management
Primary Purpose
Anemia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pronto® hemoglobin measurement tool
Sponsored by
About this trial
This is an interventional diagnostic trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- Adults and children >=3kg that are planned to undergo elective surgery
- Written informed consent
Exclusion Criteria:
- no written informed consent
Sites / Locations
- Johannes Gutenbert University Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
noninvasive measurement of hemoglobin
Arm Description
All participating patients are measured by the Pronto® hemoglobin measurement tool
Outcomes
Primary Outcome 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.
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
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%.
Agreement between invasive and noninvasive measurement in adults and children
Noninvasive haemoglobin measurement values are compared with invasive haemoglobin measurement values
Full Information
NCT ID
NCT03586141
First Posted
June 21, 2018
Last Updated
February 17, 2019
Sponsor
Johannes Gutenberg University Mainz
1. Study Identification
Unique Protocol Identification Number
NCT03586141
Brief Title
Pronto for Patient Blood Management
Official Title
Validation of Hb-measurement of Pronto ® as Screening Tool for Preoperative Diagnostic of Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 22, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
measurement of hemoglobin by a noninvasive sensor clip
Masking
None (Open Label)
Allocation
N/A
Enrollment
1129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
noninvasive measurement of hemoglobin
Arm Type
Other
Arm Description
All participating patients are measured by the Pronto® hemoglobin measurement tool
Intervention Type
Diagnostic Test
Intervention Name(s)
Pronto® hemoglobin measurement tool
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
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%.
Time Frame
five to ten minutes
Secondary Outcome Measure Information:
Title
Validation of postulated non invasively measured haemoglobin value as a cut off-value 2
Description
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%.
Time Frame
five to ten minutes
Title
Agreement between invasive and noninvasive measurement in adults and children
Description
Noninvasive haemoglobin measurement values are compared with invasive haemoglobin measurement values
Time Frame
five to ten minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults and children >=3kg that are planned to undergo elective surgery
Written informed consent
Exclusion Criteria:
no written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Wittenmeier, MD
Organizational Affiliation
Johannes Gutenberg University Centre, department of anaesthesiology, Langenbeckstraße 1, 55131 Mainz, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johannes Gutenbert University Centre
City
Mainz
ZIP/Postal Code
55131
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33227153
Citation
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.
Results Reference
derived
Learn more about this trial
Pronto for Patient Blood Management
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