跳至主要内容
临床试验/NCT05848362
NCT05848362尚未招募不适用

Comparison of Blood Glucose Measurement Values Taken by Different Methods in Intensive Care Unit (ICU) Patients

Uludag University0 个研究点目标入组 125 人开始时间: 2023年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
125
主要终点
Blood Glucose Measurement

研究概览

简要总结

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%.

详细描述

Purpose: In this study, it is aimed to compare whether there is a difference between blood samples from venous, arterial, capillary, and thumb base regions, 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.

Design: This is a quasi-experimental study with a single group and simultaneous (matched) sample will conduct 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.

A central venous catheter blood sample will be taken from the patient by the guideline recommendations and placed in the biochemistry tube and taken to the laboratory by the researchers. This result is studied by the "biochemistry-glucose test" laboratory.

A capillary blood sample (right/left fingertip; thumb base) from the same patient will be evaluated with a glucometer (Accu-check).

Finally, from the same patient, the transducer set to which the arterial catheterization is connected will first be washed with 5 ccs 1% heparin, and blood glucose will be measured by taking a blood sample from the catheter. Then, it will be washed with 10 ccs 1% heparin and a blood sample will be taken from the catheter and blood glucose measurement will be made. An arterial blood sample (right/left fingertip; thumb base) from the same patient will be evaluated with a glucometer (Accu-check).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

盲法说明

single group sample, there is no blinding as everyone will be treated equally

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • patients who have predibatic will be excluded from the study. The research has been added to the exclusion criteria and has been changed both in the relevant field in the system and in the project application file. In the ADA (American Diabetes Association) definition of prediabetes, IGT (Impaired Glucose Tolerance) (140-200 mg/dl), lower IAG (Impaired Fasting Glucose) (100-125 mg/dl) and additional supplementation according to WHO (World Health Organization) It is based on the criteria of hemoglobin A1c (HbA1c: Hemoglobin A1c) between 5.7% and 6.4% (ADA,2014). Meeting one of the three criteria is defined as prediabetes. Prediabetes screening is performed using 75 g OGTT, HbA1C, FPG, or a 2-hour oral glucose challenge test.
  • 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)

结局指标

主要结局

Blood Glucose Measurement

时间窗: baseline

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

次要结局

  • Behavioral Pain Scale(through study completion, an average of 1 year)
  • Visual Analog Scale(through study completion, an average of 1 year)

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hulya Yilmaz

Pirincipal Investigator, PhD, Msc

Uludag University

相似试验

Comparison of Blood Glucose Measurement Values | 临床试验