SpHb Perioperatively

NCT04391517 | Completed

• 1 other identifier: SpHbv1.2
• Study Type: interventional
• Target: 1,284
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Anemia, Iron Deficiency

Keywords

Patient Blood Management; Perioperative; Anemia

Outcome Measures

Primary Outcomes (2)

• SpHb Accuracy

  Accuracy (trueness and precision) of non-invasive Hb measurement

  before surgery

• SpHb Cut-off

  Potential SpHb cut-offs to reliably non-invasively detect anaemia as defined by the gold-standard

  before surgery

Study Arms (1)

Study Population

EXPERIMENTAL

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.

Diagnostic Test: SpHb measurement

Interventions

SpHb measurement DIAGNOSTIC_TEST

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.

Study Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patient planned for elective surgery
• Patient undergoing pre-operative evaluation by an anaesthesiologist
• Informed consent

You may not qualify if:

• Age \< 18 years
• Patient refusal
• Emergency surgery
• No central laboratory Hb test available

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Landeskrankenhaus Universitätsklinikum Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gabriel Honnef, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 18, 2020
• Study Start: January 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)