Arterial Cannulation in Intensive Care UnitNCT04001764
Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
A study testing The radial artery cannulation over 2 cm of the wrist, The radial artery cannulation in the distal 3/4 area of the forearm and The radial artery cannulation in the distal 1/2 area of the forearm in people with Arterial Cannulation in Intensive Care Unit and Catheterization, Peripheral, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this prospective, randomized, open-labeled study, the intensive care patients will be selected for ultrasound-guided cannulation of the radial artery in three different regions. Patients will be divided into three groups with simple randomization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Cannulation in Intensive Care Unit, Catheterization, Peripheral, Radial Artery
- What is being tested?
- The radial artery cannulation over 2 cm of the wrist, The radial artery cannulation in the distal 3/4 area of the forearm and The radial artery cannulation in the distal 1/2 area of the forearm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2019to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission of the first degree relatives of the patients and if the patient can give consent
- Patients over 18
- Non-pregnant patients
- Patients without inotropic/vasopressor support
- Patients who do not have contraindications for radial artery cannulation (thrombosis in the distal region, a focus of infection at the site of entry, lack of adequate collateral flow in the Allen test, peripheral vascular diseases [eg, Raynaud's disease)]
Who cannot join
- Patient/Patient's first degree relatives refuse to work
- Patients under 18
- Pregnant patients
- Patients with contraindications for radial artery cannulation (thrombosis in the distal region, a focus of infection at the site of entry, lack of adequate collateral flow in the Allen test, peripheral vascular diseases [eg, Raynaud's disease)]
- Patient's inotropic/vasopressor support
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Training and Research Hospital
Izmir, Karabaglar, 35170
About this study
In this prospective, randomized, open-labeled study, the intensive care patients will be selected for ultrasound-guided cannulation of the radial artery in three different regions. Patients will be divided into three groups with simple randomization. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Whether there is a difference in the duration of use of arterial cannula, first entry success rates, duration of intervention, number of procedures, the number of cannulas used and the effects on early and late complications and advantages between the groups will be investigated.
Read the detailed description
In patients requiring frequent arterial blood gas sampling in the intensive care unit and in cases requiring continuous blood pressure monitoring, arterial cannulation is preferred. The use of USG has also become widespread in anesthesia practice. It is supported by studies that USG-guided interventions cause fewer complications compared to classical methods and reduce intervention time. USG-guided arterial catheterization method is based on the principle of direct visualization of the artery and catheter via USG. In this technique, the catheter and the needle tip are displayed simultaneously with the USG guided to the artery lumen. Imaging of anatomical structures with USG has resulted in a reduction of complications and shortening of the processing time. In the USG screen, adjacent anatomical formations such as veins and nerve structures are simultaneously displayed. This reduces the risk of complications.
Two different techniques are used for USG mediated radial artery cannulation. The first one is the in-plane technique, which forms the long axis image of the arteries by positioning the USG probe to parallel to the vein, and the second is the out-of-plane technique, which forms a short axis image with the probe positioned perpendicular to the arteries.
The ideal location of radial artery catheterization with USG or the advantages/disadvantages of the catheterization zone are not available.
In this randomized prospective and open-label study, patients will be divided into three groups. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Comparison of these three groups, in terms of duration of use of arterial cannula, initial entry success rates, duration of intervention, number of procedures used, number of cannulas used and effects on early and late complications, and advantages if any is intended.
Patients will be randomly distributed to three groups. Diagnosis, age, sex, height, weight, and body mass index of the patients will be recorded. The random distribution of obese patients to groups will be ensured. Allen test will be done to the patients before the intervention. Radial artery catheterization will be applied only to patients with the collateral flow. Each group will be measured and recorded before, during and after the intervention. Before the intervention, local anesthetic infiltration will be applied and asepsis will be provided. Early complications (such as hematoma, hemorrhage) and late complications (such as circulatory disorders) will be observed and recorded.
- Being tested
- The radial artery cannulation over 2 cm of the wrist, The radial artery cannulation in the distal 3/4 area of the forearm, The radial artery cannulation in the distal 1/2 area of the forearm
- Keywords
- Arterial Catheterization, Peripheral Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The radial artery cannulation over 2 cm of the wristProcedure or surgery
The radial artery catheterization performed as short axis out-of-plane with USG over 2 cm of the wrist.
The radial artery cannulation in the distal 3/4 area of the forearmProcedure or surgery
The radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention.
The radial artery cannulation in the distal 1/2 area of the forearmProcedure or surgery
The radial artery catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane intervention.
| Study group | Role | What they receive |
|---|---|---|
| The first group | Active comparator | The radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. Receives: Procedure: The radial artery cannulation over 2 cm of the wrist |
| The second group | Experimental | The radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. Receives: Procedure: The radial artery cannulation in the distal 3/4 area of the forearm |
| The third group | Experimental | The radial artery catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane intervention. Receives: Procedure: The radial artery cannulation in the distal 1/2 area of the forearm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Use of Arterial Cannula
From the time arterial cannula is successfully inserted until cannula cannot use
Measured: During Procedure
Secondary outcomes (5)
Initial Entry Success Rates
Success or fail of initial entry
Measured: During procedure
Duration of Intervention
Time from the beginning of procedure and successful cannulation of radial artery
Measured: During procedure
Number of Punctures
Count of punctures until successful artery cannulation
Measured: During procedure
Early Complications
Complications seen during procedure
Measured: During procedure
Late Complications
Complications seen after successful completion of artery cannulation
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start30 Jul 2019
- Primary completion10 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arterial Cannulation in Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeki T. TEKGUL, Assoc. Prof., Study director, Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001764
- Sponsor's protocol ID
- direnctez
- Status last verified
- Dec 2019
- First submitted
- 15 Jun 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hansen MA, Juhl-Olsen P, Thorn S, Frederiksen CA, Sloth E. Ultrasonography-guided radial artery catheterization is superior compared with the traditional palpation technique: a prospective, randomized, blinded, crossover study. Acta Anaesthesiol Scand. 2014 Apr;58(4):446-52. doi: 10.1111/aas.12299. Epub 2014 Mar 3.
PubMed 24588456Quan Z, Tian M, Chi P, Cao Y, Li X, Peng K. Modified short-axis out-of-plane ultrasound versus conventional long-axis in-plane ultrasound to guide radial artery cannulation: a randomized controlled trial. Anesth Analg. 2014 Jul;119(1):163-169. doi: 10.1213/ANE.0000000000000242.
PubMed 24806143Levin PD, Sheinin O, Gozal Y. Use of ultrasound guidance in the insertion of radial artery catheters. Crit Care Med. 2003 Feb;31(2):481-4. doi: 10.1097/01.CCM.0000050452.17304.2F.
PubMed 12576955Shiver S, Blaivas M, Lyon M. A prospective comparison of ultrasound-guided and blindly placed radial arterial catheters. Acad Emerg Med. 2006 Dec;13(12):1275-9. doi: 10.1197/j.aem.2006.07.015. Epub 2006 Nov 1.
PubMed 17079789Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
PubMed 34637140
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT04001764
- Acronym / sponsor ID
- direnctez
- Keywords
- Arterial Catheterization, Peripheral Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective, randomized, open-labeled study, the intensive care patients will be selected for ultrasound-guided cannulation of the radial artery in three different regions. Patients will be divided into three groups with simple randomization. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Whether there is a difference in the duration of use of arterial cannula, first entry success rates, duration of intervention, number of procedures, the number of cannulas used and the effects on early and late complications and advantages between the groups will be investigated.
Detailed description
In patients requiring frequent arterial blood gas sampling in the intensive care unit and in cases requiring continuous blood pressure monitoring, arterial cannulation is preferred. The use of USG has also become widespread in anesthesia practice. It is supported by studies that USG-guided interventions cause fewer complications compared to classical methods and reduce intervention time. USG-guided arterial catheterization method is based on the principle of direct visualization of the artery and catheter via USG. In this technique, the catheter and the needle tip are displayed simultaneously with the USG guided to the artery lumen. Imaging of anatomical structures with USG has resulted in a reduction of complications and shortening of the processing time. In the USG screen, adjacent anatomical formations such as veins and nerve structures are simultaneously displayed. This reduces the risk of complications.
Two different techniques are used for USG mediated radial artery cannulation. The first one is the in-plane technique, which forms the long axis image of the arteries by positioning the USG probe to parallel to the vein, and the second is the out-of-plane technique, which forms a short axis image with the probe positioned perpendicular to the arteries.
The ideal location of radial artery catheterization with USG or the advantages/disadvantages of the catheterization zone are not available.
In this randomized prospective and open-label study, patients will be divided into three groups. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Comparison of these three groups, in terms of duration of use of arterial cannula, initial entry success rates, duration of intervention, number of procedures used, number of cannulas used and effects on early and late complications, and advantages if any is intended.
Patients will be randomly distributed to three groups. Diagnosis, age, sex, height, weight, and body mass index of the patients will be recorded. The random distribution of obese patients to groups will be ensured. Allen test will be done to the patients before the intervention. Radial artery catheterization will be applied only to patients with the collateral flow. Each group will be measured and recorded before, during and after the intervention. Before the intervention, local anesthetic infiltration will be applied and asepsis will be provided. Early complications (such as hematoma, hemorrhage) and late complications (such as circulatory disorders) will be observed and recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The first group | Active comparator | Procedure: The radial artery cannulation over 2 cm of the wristThe radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. |
| The second group | Experimental | Procedure: The radial artery cannulation in the distal 3/4 area of the forearmThe radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. |
| The third group | Experimental | Procedure: The radial artery cannulation in the distal 1/2 area of the forearmThe radial artery catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admission of the first degree relatives of the patients and if the patient can give consent
- Patients over 18
- Non-pregnant patients
- Patients without inotropic/vasopressor support
- Patients who do not have contraindications for radial artery cannulation (thrombosis in the distal region, a focus of infection at the site of entry, lack of adequate collateral flow in the Allen test, peripheral vascular diseases [eg, Raynaud's disease)]
Key exclusion criteria (5 listed)
- Patient/Patient's first degree relatives refuse to work
- Patients under 18
- Pregnant patients
- Patients with contraindications for radial artery cannulation (thrombosis in the distal region, a focus of infection at the site of entry, lack of adequate collateral flow in the Allen test, peripheral vascular diseases [eg, Raynaud's disease)]
- Patient's inotropic/vasopressor support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The radial artery cannulation over 2 cm of the wristThe radial artery catheterization performed as short axis out-of-plane with USG over 2 cm of the wrist. | Procedure or surgery | The first group |
| The radial artery cannulation in the distal 3/4 area of the forearmThe radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. | Procedure or surgery | The second group |
| The radial artery cannulation in the distal 1/2 area of the forearmThe radial artery catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane intervention. | Procedure or surgery | The third group |
Primary outcome
Duration of Use of Arterial Cannula
Time frame: During Procedure
From the time arterial cannula is successfully inserted until cannula cannot use
5 secondary outcomes
Initial Entry Success Rates
Time frame: During procedure
Duration of Intervention
Time frame: During procedure
Number of Punctures
Time frame: During procedure
Early Complications
Time frame: During procedure
Late Complications
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Background: PubMed 24588456Hansen MA, Juhl-Olsen P, Thorn S, Frederiksen CA, Sloth E. Ultrasonography-guided radial artery catheterization is superior compared with the traditional palpation technique: a prospective, randomized, blinded, crossover study. Acta Anaesthesiol Scand. 2014 Apr;58(4):446-52. doi: 10.1111/aas.12299. Epub 2014 Mar 3.
- Background: PubMed 24806143Quan Z, Tian M, Chi P, Cao Y, Li X, Peng K. Modified short-axis out-of-plane ultrasound versus conventional long-axis in-plane ultrasound to guide radial artery cannulation: a randomized controlled trial. Anesth Analg. 2014 Jul;119(1):163-169. doi: 10.1213/ANE.0000000000000242.
- Background: PubMed 12576955Levin PD, Sheinin O, Gozal Y. Use of ultrasound guidance in the insertion of radial artery catheters. Crit Care Med. 2003 Feb;31(2):481-4. doi: 10.1097/01.CCM.0000050452.17304.2F.
- Background: PubMed 17079789Shiver S, Blaivas M, Lyon M. A prospective comparison of ultrasound-guided and blindly placed radial arterial catheters. Acad Emerg Med. 2006 Dec;13(12):1275-9. doi: 10.1197/j.aem.2006.07.015. Epub 2006 Nov 1.
- Derived from this study: PubMed 34637140Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeki T. TEKGUL, Assoc. Prof. study director
Izmir Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The radial artery cannulation over 2 cm of the wrist, The radial artery cannulation in the distal 3/4 area of the forearm and The radial artery cannulation in the distal 1/2 area of the forearm in people with Arterial Cannulation in Intensive Care Unit and Catheterization, Peripheral, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Use of Arterial Cannula (time frame: During Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001764, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.