Comparison of Blood Glucose Measurement Values

NCT05848362 | Unknown

• 1 other identifier: 16/03/2022 - 6/10
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose: It is one of the important nursing interventions for patients in intensive care units with strict glycemic protocol to determine whether glucose values are different for a bedside glucose meter compared to the main clinical laboratory and whether the blood sampling site has a significant effect on glucose values. In this study, it is aimed to compare whether there is a difference between blood samples from venous, arterial, capillary and thumb base region, which is defined as an alternative region to the fingertip, in blood glucose level measurement, and to compare the consistency between the thumb base region and fingertip region and pain and results of the different methods used. Methods: The universe of the research consists of Bursa Uludağ University Health Practice and Patients will be hospitalized in the General Surgery Intensive Care Unit of the Research Center between April and September 2023. 125 patients who meet the sample selection criteria will form the sample of the study. The sample size of the study was determined statistically with the G\*Power (3.1.7) program. Comparison of blood glucose measurement taken with different methods in the power analysis to determine the sample size. When the effect size of blood glucose was determined as 0.9, it was calculated that a total of 125 patients should be included for a significance level of 0.05 and a power of 80%. Research '' Ergin E., Zaybak A. (2022). Effects of different methods used to take blood samples on blood glucose measurements. Reference is made to Clinical Nursing Research, 31(1), (p.29-38).DOI: 10.1177/10547738211024782". 125 patients who meet the sample selection criteria will form the sample of the study. The sample size of the study was determined statistically with the G\*Power (3.1.7) program. When the effect size of blood glucose was determined as 0.9 in the comparison of blood glucose measurement taken with different methods in the power analysis performed to determine the sample size, it was calculated that a total of 125 patients should be included for a significance level of 0.05 and a power of 80%.

Conditions

Pain, Acute; Glucose Test Site Bleeding

Keywords

blood glucose measurements; intensive care patients; venous blood; capillary blood; arterial blood

Outcome Measures

Primary Outcomes (1)

• Blood Glucose Measurement

  In this comparison, the central venous catheter blood glucose measurement value will be taken as a baseline.

  baseline

Secondary Outcomes (2)

• Behavioral Pain Scale

  through study completion, an average of 1 year

• Visual Analog Scale

  through study completion, an average of 1 year

Study Arms (1)

SINGLE GROUP

OTHER

This is a quasi-experimental study with a single group and simultaneous (matched) sample will conduct with the purpose of to determine whether glucose values are different for a bedside glucose meter compared to the main clinical laboratory and whether the blood sampling site has a significant effect on glucose values.

Other: Blood Glucose Measurement Values Taken by Different Methods

Interventions

Blood Glucose Measurement Values Taken by Different Methods OTHER

In total, blood samples will be collected from 3 different sites (central venous catheter, capillary, arterial catheterization) in the same patient. In total, with 5 different techniques from 3 different regions from the same patient; ARTERIAL BLOOD SAMPLE i) Washing with 5 cc 1% Heparin fluid ii) Washing with 10 cc 1% Heparin fluid CAPILAR BLOOD SAMPLE iii) Right / Left Fingertip iv) Thumb base CENTRAL VENOUS CATHETERIZATION BLOOD SAMPLE will be collected.

SINGLE GROUP

Eligibility Criteria

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

You may qualify if:

• patients who age bigger than18
• patients who have capillary fullness is good
• patients who have a central venous catheter
• patients who have an arterial catheter

You may not qualify if:

• patients with Diabetes Mellitus,
• patients with coagulopathy
• patients who receive high-dose vasopressors, acetamifon, ascorbic acid, mannitol, corticosteroid, renal replacement therapy
• patients who do not agree to participate in the research,
• patients who have upper extremity amputation, cast, etc. (capillary blood sample cannot be taken for reasons)

Sponsors & Collaborators

• Uludag University: lead

Related Publications (5)

• Payen JF, Bru O, Bosson JL, Lagrasta A, Novel E, Deschaux I, Lavagne P, Jacquot C. Assessing pain in critically ill sedated patients by using a behavioral pain scale. Crit Care Med. 2001 Dec;29(12):2258-63. doi: 10.1097/00003246-200112000-00004.

  PMID: 11801819 BACKGROUND

• Pinheiro ARPQ, Marques RMD. Behavioral Pain Scale and Critical Care Pain Observation Tool for pain evaluation in orotracheally tubed critical patients. A systematic review of the literature. Rev Bras Ter Intensiva. 2019 Oct-Dec;31(4):571-581. doi: 10.5935/0103-507X.20190070.

  PMID: 31967234 BACKGROUND

• Hirose T, Mita T, Fujitani Y, Kawamori R, Watada H. Glucose monitoring after fruit peeling: pseudohyperglycemia when neglecting hand washing before fingertip blood sampling: wash your hands with tap water before you check blood glucose level. Diabetes Care. 2011 Mar;34(3):596-7. doi: 10.2337/dc10-1705. Epub 2011 Jan 31.

  PMID: 21282342 BACKGROUND

• Rabinstein AA. Hyperglycemia in critical illness: lessons from NICE-SUGAR. Neurocrit Care. 2009;11(1):131-2. doi: 10.1007/s12028-009-9240-x. Epub 2009 Jun 5. No abstract available.

  PMID: 19499351 BACKGROUND

• Ergin E, Zaybak A. Effects of Different Methods Used to Take Blood Samples on Blood Glucose Measurements. Clin Nurs Res. 2022 Jan;31(1):29-38. doi: 10.1177/10547738211024782. Epub 2021 Jul 5.

  PMID: 34218680 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hülya Yılmaz, PhD, Msc

CONTACT

+905395876207; hlyyilmaz@uludag.edu.tr

Dilan Ayhan, Msc

CONTACT

+905528966117; dln.ayhn.4436@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: single group sample, there is no blinding as everyone will be treated equally
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pirincipal Investigator, PhD, Msc

Model Details: This is a quasi-experimental study with a single group and simultaneous (matched) sample will conduct with the purpose of to determine whether glucose values are different for a bedside glucose meter compared to the main clinical laboratory and whether the blood sampling site has a significant effect on glucose values.

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 8, 2023
• Study Start: May 17, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share