SpHb Perioperatively
Primary Purpose
Anemia, Anemia, Iron Deficiency
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
SpHb measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Anemia focused on measuring Patient Blood Management, Perioperative, Anemia
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Patient planned for elective surgery
- Patient undergoing pre-operative evaluation by an anaesthesiologist
- Informed consent
Exclusion Criteria:
- Age < 18 years
- Patient refusal
- Emergency surgery
- No central laboratory Hb test available
Sites / Locations
- Landeskrankenhaus Universitätsklinikum Graz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Population
Arm Description
Included patients will be evaluated by an anaesthesiologist according to national and international guidelines as it is routine at the pre-operative clinic. In addition, all included patients will have their Hb measured non-invasively by a trained health care provider. SpHb values will be recorded in the documentation software already in use at the clinic.
Outcomes
Primary Outcome Measures
SpHb Accuracy
Accuracy (trueness and precision) of non-invasive Hb measurement
SpHb Cut-off
Potential SpHb cut-offs to reliably non-invasively detect anaemia as defined by the gold-standard
Secondary Outcome Measures
Full Information
NCT ID
NCT04391517
First Posted
May 2, 2020
Last Updated
November 15, 2022
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT04391517
Brief Title
SpHb Perioperatively
Official Title
Non-invasive Measurement of Serum Haemoglobin in a Perioperative Setting
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
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
This study's goal is to establish SpHb threshold values that can help health care provider sort out which patients would potentially benefit from central laboratory Hb testing pre-operatively and who would likely not. It also aims to compare the mean difference between these two methods in a pre-operative setting.
SpHb values will be observed and recorded from patients meeting the inclusion criteria undergoing pre-operative evaluation for plastic, trauma, orthopaedic, urological, general and gynaecological surgery over one year by the Department of Anaesthesiology and Intensive Care Medicine at the University Medical Centre Graz.
All patients will be evaluated pre-operatively by an anaesthesiologist, utilizing both central laboratory measurements as clinical routine and non-invasive Hb measurements. Both measurements (SpHb and central laboratory Hb) will be documented, along with the normally collected patient data, using the electronic system currently in use. Median values from the two methods will be compared, and possible cut-off values calculated.
Detailed Description
Knowledge of patients' serum haemoglobin (Hb) levels is of great importance in many areas of medical practice. Standard methods of measurement require direct blood sampling; they are therefore relatively invasive, costly, and time-consuming.
Non-invasive Hb measurement techniques utilizing a finger probe (SpHb) have attracted a lot of attention over the last five years. Numerous studies have compared the accuracy of these devices with central laboratory Hb data in a wide range of clinical settings: operating rooms, critical care units, emergency departments, and blood donor clinics.
A meta-analysis of previous studies regarding SpHb measurements in perioperative and intensive care settings has revealed a mean difference between non-invasive and central laboratory Hb results of 0.10±1.37 g/dl (n=4425) (2) . To date, however, few studies have assessed the use of these devices in a pre-operative setting.
Such a study could be of great value, as Hb measurement plays an important role in the implementation of PBM programmes (Patient Blood Management), which in turn are associated with improved patient outcomes, fewer transfusions and lower costs.
Various guidelines with the aim of reducing unnecessary testing have been proposed. Such guidelines prioritize the tests to be applied during preparation for minor, intermediate and major surgery, considering specific comorbidities.
This study's goal is to establish SpHb threshold values that can help health care provider sort out which patients would potentially benefit from central laboratory Hb testing pre-operatively and who would likely not. It also aims to compare the mean difference between these two methods in a pre-operative setting.
With reliable cut-off values, SpHb levels could serve as a pre-test for patients with a low ASA (American Society of Anesthesiologists) score undergoing minor to intermediate surgery-i.e., those who would normally not receive a complete lab-test before an operation. This adaptation of clinical routine could help to detect anemia where it might otherwise be missed.
To achieve this goal, SpHb values will be observed and recorded from patients meeting the inclusion criteria undergoing pre-operative evaluation for plastic, trauma, orthopaedic, urological, general and gynaecological surgery over one year by the Department of Anaesthesiology and Intensive Care Medicine at the University Medical Centre Graz.
All patients will be evaluated pre-operatively by an anaesthesiologist, utilizing both central laboratory measurements as clinical routine and non-invasive Hb measurements. Both measurements (SpHb and central laboratory Hb) will be documented, along with the normally collected patient data, using the electronic system currently in use. Median values from the two methods will be compared, and possible cut-off values calculated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Anemia, Iron Deficiency
Keywords
Patient Blood Management, Perioperative, Anemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Population
Arm Type
Experimental
Arm Description
Included patients will be evaluated by an anaesthesiologist according to national and international guidelines as it is routine at the pre-operative clinic. In addition, all included patients will have their Hb measured non-invasively by a trained health care provider. SpHb values will be recorded in the documentation software already in use at the clinic.
Intervention Type
Diagnostic Test
Intervention Name(s)
SpHb measurement
Intervention Description
All included patients will have their Hb measured non-invasively by a trained health care provider. SpHb values will be recorded in the documentation software already in use at the clinic.
Primary Outcome Measure Information:
Title
SpHb Accuracy
Description
Accuracy (trueness and precision) of non-invasive Hb measurement
Time Frame
before surgery
Title
SpHb Cut-off
Description
Potential SpHb cut-offs to reliably non-invasively detect anaemia as defined by the gold-standard
Time Frame
before surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Patient planned for elective surgery
Patient undergoing pre-operative evaluation by an anaesthesiologist
Informed consent
Exclusion Criteria:
Age < 18 years
Patient refusal
Emergency surgery
No central laboratory Hb test available
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Honnef, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landeskrankenhaus Universitätsklinikum Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
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