NCT03586141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,129

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

July 22, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

June 21, 2018

Last Update Submit

February 17, 2019

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Validation of postulated non invasively measured haemoglobin value as a cut off-value 2

    five to ten minutes

  • Agreement between invasive and noninvasive measurement in adults and children

    five to ten minutes

Study Arms (1)

noninvasive measurement of hemoglobin

OTHER

All participating patients are measured by the Pronto® hemoglobin measurement tool

Diagnostic Test: Pronto® hemoglobin measurement tool

Interventions

Pronto® hemoglobin measurement toolDIAGNOSTIC_TEST

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

noninvasive measurement of hemoglobin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • no written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Gutenbert University Centre

Mainz, 55131, Germany

Location

Related Publications (2)

  • Mohnke K, Smetiprach J, Paumen Y, Mildenberger P, Komorek Y, Griemert EV, Wittenmeier E. Is noninvasive hemoglobin measurement suitable for children undergoing preoperative anesthesia consultation? J Clin Monit Comput. 2025 Feb;39(1):175-182. doi: 10.1007/s10877-024-01194-7. Epub 2024 Jul 20.

    PMID: 39031232DERIVED

  • 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.

    PMID: 33227153DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Eva Wittenmeier, MD

    Johannes Gutenberg University Centre, department of anaesthesiology, Langenbeckstraße 1, 55131 Mainz, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: measurement of hemoglobin by a noninvasive sensor clip
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 13, 2018

Study Start

July 22, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

February 19, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)