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Not yet recruitingNCT05911581Updated Jun 22, 2023

The Effect of the Use of Washing Solutions at Different Temperatures Used in Intra-arterial Cannulation

An interventional study of intra-arterial flushing and intra-arterial flushing in Intrarterial Catheterization, sponsored by Bursa Yüksek İhtisas Education and Research Hospital. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Bursa Yüksek İhtisas Education and Research Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Nowadays, intraarterial catheterization is frequently used as an invasive method for intraoperative blood pressure monitoring and control.The radial artery is frequently used in this procedure and the cannula should be flushed with 2-3 ml of heparinized fluid intermittently to prevent occlusion. During the operation, the ambient temperature is approximately 22-24 C and the patient temperature can be 34-36 C. Since the flushing fluids are also in the environment, they are 22-24 C. The aim of this study is to determine whether the fluids at room temperature cause vasoconstriction in the vessel and cause a change in blood pressure arterial values.

Read the detailed description

The aim of this study is to determine whether room temperature fluids cause vasoconstriction or vasodilatation in the vessel and cause a change in blood pressure arterial values.

02

Conditions studied

  • Intrarterial Catheterization
03

In context

Lead sponsor

Bursa Yüksek İhtisas Education and Research Hospital is the lead sponsor of 62 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • risk class,
  • Medically undergoing intra-arterial cannulation
  • Being between the ages of 18-70

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of DM
  • Vascular disease,
  • Bleeding diathesis,
  • inotropic drug use
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    room temperature washing solution

    İntra-arterial flushing with heparinized fluid kept in room air

    Other: intra-arterial flushing

  • Active comparator
    washing solution at patient temperature

    Intra-arterial flushing with heparinized fluid at patient body temperature

    Other: intra-arterial flushing

Interventions

  • Otherintra-arterial flushing

    The catheter will be flushed to prevent occlusion after radial artery catheterization. intra-arterial flushing with heparinized fluid kept in room air

    Also known as: group room

  • Otherintra-arterial flushing

    Intra-arterial flushing with heparinized fluid at patient body temperature

    Also known as: group patient

06

What researchers measure

Primary outcomes

  1. Arterial flow velocities PSV

    After flushing performed , peak systolic velocity (PSV) values in the radial artery by Ultrasound doppler method.

    Time frame: 30th seconds after arterial flush

  2. Arterial flow velocities End-diastolic velocity

    After flushing performed , end- diastolic velocity (EDV) values in the radial artery by ultrasound doppler method;

    Time frame: 30th seconds after arterial flush

  3. Arterial flow velocities resistive indices

    After flushing performed resistive indices (RI) values in the radial artery by ultrasound doppler method.

    Time frame: 30th seconds after arterial flush

Secondary outcomes

  1. invasive and non-invasive blood pressure

    After flushing performed systolic, diastolic, and average blood pressure values measured

    Time frame: 10th,30th,60th,90th ,120th and 150th seconds

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2023; primary completion for Dec 2023, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2023
First posted
Jun 22, 2023
StartEst.
Jun 16, 2023
Primary completionEst.
Dec 30, 2023
CompletionEst.
Jan 15, 2024
Last update
Jun 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05911581
Lead sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible party
Korgün Ökmen (Assoc.Phd.M.D, Bursa Yüksek İhtisas Education and Research Hospital) — Principal investigator
First posted
Jun 22, 2023
Start date
Jun 16, 2023 (estimated)
Primary completion
Dec 30, 2023 (estimated)
Completion
Jan 15, 2024 (estimated)
Last update
Jun 22, 2023

Study contacts

Korgün Ökmen, Assoc. PhD.
Contact
korgunokmen@gmail.com
+905057081021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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