The primary objective of this study is to investigate the accuracy of a BTD on blood collection tubes. This prevents air exposure wherefore all the available blood gas results (pH, bicarbonate, pCO2, pO2, oxygen saturation, lactate, ionised calcium…
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Brief title
Condition
- Other condition
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Health condition
patiënten voor wie een bloedgasanalyse is geïndiceerd
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of this study is to optimize VBG sampling, by testing the
accuracy of VBG results obtained through the use of a blood transfer device
(BTD). We will evaluate a comprehensive set of blood gas results (pH,
bicarbonate, pCO2, pO2, oxygen saturation, lactate, ionised calcium, sodium,
chloride, potassium, haemoglobin, FCOHb, FMethHb) from a VBG samples collected
via a BTD.
We will compare VBG results collected in three different tubes methods by using
the same blood draw from an IV line:
1) directly into a blood gas syringe (golden standard referred to as blood gas
syringe)
2) into a heparin tube and subsequently transferred to a capillary (referred to
as capillary VBG)
3) Into a dummy tube and subsequently transferred to a blood gas syringe via a
BTD (referred to as adapter VBG).
Secondary outcome
1. Evaluate influence of a different tube sequence: according to the CLSI and
NVKC, tubes should be drawn in a specific sequence as the sequence may
influence results. According to this guideline, a VBG should be drawn first in
the sequence. However, it would be more practical to take a VBG at the end. We
will test whether taking a VBG at the end of the sequence would influence blood
gas results.
2. Following the sequence, a conventional VBG is immediately drawn in a blood
gas syringe, but it can also be taken from a heparinized tube and then
transferred to a blood gas syringe. It is not clear what the effect of heparin
is on blood gas results, wherefore it is currently taken in a tube without
anticoagulation (dummy tube). However, the use of a heparinized tube will
minimize the risk for in vitro blood clotting, that can interfere with results.
3. The effect of storage (room temperature or on ice), time-to analysis and
transport (pneumatic tube) have not been adequately described.
Background summary
Blood gas analyses are crucial in the assessment of critically ill patients,
especially in emergency and intensive care settings. Traditionally, the gold
standard for these analyses has been arterial blood gas sampling (ABG).
However, ABG sampling is associated with an invasive, painful, and technically
challenging procedure that requires skilled phlebotomists. Increasingly, venous
blood sampling (VBG) as an alternative for blood gas analysis is gaining
popularity. VBG is obtained through venipuncture, a standard method of blood
collection that can be performed by any trained personnel. Previous research
has demonstrated that VBG sampling is a reliable alternative, showing a strong
correlation between venous and arterial pH as well as bicarbonate levels.
The use of a VBG facilitates that samples can be collected during routine
venipuncture and enables nurses, rather than laboratory staff, to perform the
collection at the department. However, this approach also entails specific
pre-analytic variables, such as exposure to environmental air, transport time,
or collection method, e.g. samples taken through a peripheral intravenous line
(IV) or using a blood transfer device (BTD).
Study objective
The primary objective of this study is to investigate the accuracy of a BTD on
blood collection tubes. This prevents air exposure wherefore all the available
blood gas results (pH, bicarbonate, pCO2, pO2, oxygen saturation, lactate,
ionised calcium, sodium, chloride, potassium, haemoglobin, FCOHb, FMethHb)
should be similar as a VBG from a central venous line. It will be evaluated
whether this will reduce pre-analytic errors, can improve workflow, and will be
cost-effective.
Study design
Hospitalized patients will be asked to participate in this study. During the
regular venipuncture, a maximum of 30 mL additional blood will be collected. We
will collect blood directly in a blood gas syringe (syringe VBG), in a heparine
tube for transfer to a capillary (capillary VBG), and in a dummy tube
transferred with a blood transfer device to a blood gas syringe (adapter VBG).
These samples will be analysed with a bloodgas analyzer. If the adapter VBG
produces accurate results as compared to the syringe VBG, we will test various
pre-analytical variables as described in secondary objectives.
We will collaborate with medical doctors who requested a blood gas analysis for
these patients. The medical doctor will order a laboratory test and will
inquire whether the patient wants to participate in the study. These patients
include subjects on the first aid and intensive care who are competent to
adequate answer questions.
Blood will be drawn by qualified and experienced personnel, and patients will
be asked to give informed consent, after reading and discussing all the
relevant information and their questions. Previous experiences have shown that
patients are highly motivated to participate in research studies that will
improve diagnostics and health.
This study consists of two parts. The main purpose of this study is to perform
a method comparison between the capillary VBG and an adapter VBG. Results will
be obtained by our regular blood gas analyzer. For this, we will compare
capillary VBG vs. syringe VBG results with adapter VBG vs. syringe VBG results.
VBG will be collected using the same blood draw from an IV line. If results of
the adapter VBG show a smaller bias, we can proceed with part two: optimizing
the workflow by testing various pre-analytic variables as described in the
secondary objectives. Results will be compared with a syringe VBG.
Study burden and risks
Blood samples will be collected by qualified healthcare personnel. Drawing
blood is a routine diagnostic procedure and will be conducted in compliance
with the department's safety guidelines. The total amount of additional blood
will be a maximum of 30 mL per subject and will be drawn from the same
venipuncture made for diagnostic purposes. Although a needle puncture might
cause a hematoma, no additional needle puncture is necessary, wherefore we
consider this study at minimal risk for the patient.
Maatweg 3
Amersfoort 3813 TZ
NL
Maatweg 3
Amersfoort 3813 TZ
NL
Listed location countries
Age
Inclusion criteria
Hospitalized patients patients who require a bloodgas analysis
Exclusion criteria
Patients younger than 18 years old and incompetent patients
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL86451.100.24 |