AnesthesiaNCT03405428
Ultrasonography For Radial Artery Diameter Measurement And Its Correlation With Allen Test
A study testing Allen test, Radial artery diameter measurement by ultrasonography and Ulnar artery doppler ultrasonography in people with Anesthesia and Ultrasonography, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators will investigate how patients' radial artery diameters change according to sex, age, height, weight and body mass index by measuring radial artery diameter using ultrasonography. The correlation of Allen test with doppler ultrasonography will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia, Ultrasonography, Radial Artery
- What is being tested?
- Allen test, Radial artery diameter measurement by ultrasonography and Ulnar artery doppler ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 30 Apr 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients will be operated under general anesthesia
- patients were American Society of Anesthesiology (ASA) physical status I or II
Who cannot join
- ASA III, IV, V
- History of coroner artery disease
- History of peripheral artery disease,
- History of diabetes mellitus,
- History of hypertension
- Hemodynamic instability
Show all 10Show fewer
- Hypovolemia
- History of Reynaud phenomenon
- History of hand or arm trauma
- previous catheterization
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Cerrahpasa Medical Faculty
Istanbul
Ayşe Sıla Akkuş, 00905553044975, aysesilaakkus@hotmail.com
About this study
Official title: Radial Artery Diameter Measurement By Ultrasonography For Determination Of Proper Cannula Size And Investigation Of Correlation Between Allen Test And Doppler Ultrasonography
In this study, the investigators will investigate how patients' radial artery diameters change according to sex, age, height, weight and body mass index by measuring radial artery diameter using ultrasonography. The correlation of Allen test with doppler ultrasonography will also be evaluated.
Read the detailed description
Arterial catheterization for continuous hemodynamic monitoring or frequent blood sampling is a common procedure in anesthesia and critical care setting. The most commonly used site for arterial catheterization is the radial artery because of its superficial course, alternate blood supply to hand via ulnar artery and a low rate of complications. Allen test is a simple, but not reliable, method for assessing the safety of radial artery catheterization. Intraarterial catheterization has some complications such as hematoma, vasospasm, arterial thrombosis, necrosis of skin overlying. Using larger size cannula from radial artery diameter, increase rate of complications. The purpose of this study is to investigate the corelation of radial artery diameter with sex, age, height, weight and body mass index for determination of proper cannula size and investigation of correlation between Allen test and doppler ultrasonography.
- Conditions
- Anesthesia, Ultrasonography, Radial Artery, Catheterization
- Being tested
- Allen test, Radial artery diameter measurement by ultrasonography, Ulnar artery doppler ultrasonography
- Keywords
- Ultrasonography, Radial Artery Diameter, Allen Test, Arterial Cannulation, Doppler Ultrasonography, Ulnar Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allen testOther
Before induction, with firm occlusive pressure held on both the radial and ulnar arteries, the patient is asked to clench his or her fist several times until the palmar skin is blanched. The patient is then instructed to unclench the fist, and then ulnar artery pressure is released while maintaining occlusion of the radial artery. Overextension of the hand and wide spreading of the fingers should be avoided because it can lead to falsely abnormal results. The time required for palmar capillary refill is noted. An abnormal Allen test result was defined as a recovery time of more than 10 seconds.
Radial artery diameter measurement by ultrasonographyOther
Ultrasonography measurements will be performed with a linear probe before and after induction. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degrees with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial artery will be scanned. The diameter of the radial artery will be measured and recorded.
Ulnar artery doppler ultrasonographyOther
Ultrasonography measurements will be performed with a linear probe before and after induction. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degrees with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the ulnar arter will be scanned. The blood fow of ulnar artery will be measured and recorded.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | Not described Receives: Other: Allen test; Other: Radial artery diameter measurement by ultrasonography; Other: Ulnar artery doppler ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the radial artery diameter according to sex, age, height, weight and body mass index
Ultrasonography measurements will be performed with a linear probe. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degree with a wrist pad. The Ultrasonography probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial artery will be scanned. The diameter of the radial artery will be measured and recorded.
Measured: 5 minutes prior to anesthesia induction
Secondary outcomes (2)
correlation between Allen test and doppler ultrasonography.
Before induction, with firm occlusive pressure held on both the radial and ulnar arteries, the patient is asked to clench his or her fist several seconds until the palmar skin is blanched. The patient is then instructed to unclench the fist, and then ulnar artery pressure is released while maintaining occlusion of the radial artery. The time required for palmar capillary refill is noted. An abnormal Allen test result was defined as a recovery time of more than 10 seconds. Ultrasonography measurements will be performed with a linear probe. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degree with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the ulnar artery will be scanned. The blood fow of ulnar artery will be measured and recorded.
Measured: 5 minutes prior to anesthesia induction
change of the radial artery diameter according to sex, age, height, weight and body mass index after the induction
Ultrasonography measurements will be performed with a linear probe. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degree with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial arter will be scanned. The diameter of the radial artery will be measured and recorded.
Measured: 5 minutes following to anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Feb 2018
- Primary completion1 Apr 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guniz M.Koksal, Istanbul University
- Investigators
- Güniz Meyancı Köksal, Prof., Principal investigator, Istanbul University Cerrahpasa Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405428
- Sponsor's protocol ID
- 419999
- Status last verified
- Mar 2018
- First submitted
- 4 Jan 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Artery Diameter Measurement By Ultrasonography For Determination Of Proper Cannula Size And Investigation Of Correlation Between Allen Test And Doppler Ultrasonography
- ClinicalTrials.gov ID
- NCT03405428
- Acronym / sponsor ID
- 419999
- Conditions
- Anesthesia, Ultrasonography, Radial Artery, Catheterization
- Keywords
- Ultrasonography, Radial Artery Diameter, Allen Test, Arterial Cannulation, Doppler Ultrasonography, Ulnar Artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 23 Jan 2018 (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 study, the investigators will investigate how patients' radial artery diameters change according to sex, age, height, weight and body mass index by measuring radial artery diameter using ultrasonography. The correlation of Allen test with doppler ultrasonography will also be evaluated.
Detailed description
Arterial catheterization for continuous hemodynamic monitoring or frequent blood sampling is a common procedure in anesthesia and critical care setting. The most commonly used site for arterial catheterization is the radial artery because of its superficial course, alternate blood supply to hand via ulnar artery and a low rate of complications. Allen test is a simple, but not reliable, method for assessing the safety of radial artery catheterization. Intraarterial catheterization has some complications such as hematoma, vasospasm, arterial thrombosis, necrosis of skin overlying. Using larger size cannula from radial artery diameter, increase rate of complications. The purpose of this study is to investigate the corelation of radial artery diameter with sex, age, height, weight and body mass index for determination of proper cannula size and investigation of correlation between Allen test and doppler ultrasonography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Other: Allen test, Other: Radial artery diameter measurement by ultrasonography, Other: Ulnar artery doppler ultrasonography |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients will be operated under general anesthesia
- patients were American Society of Anesthesiology (ASA) physical status I or II
Key exclusion criteria (10 listed)
- ASA III, IV, V
- History of coroner artery disease
- History of peripheral artery disease,
- History of diabetes mellitus,
- History of hypertension
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 |
|---|---|---|
| Allen testBefore induction, with firm occlusive pressure held on both the radial and ulnar arteries, the patient is asked to clench his or her fist several times until the palmar skin is blanched. The patient is then instructed to unclench the fist, and then ulnar artery pressure is released while maintaining occlusion of the radial artery. Overextension of the hand and wide spreading of the fingers should be avoided because it can lead to falsely abnormal results. The time required for palmar capillary refill is noted. An abnormal Allen test result was defined as a recovery time of more than 10 seconds. | Other | All patients |
| Radial artery diameter measurement by ultrasonographyUltrasonography measurements will be performed with a linear probe before and after induction. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degrees with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial artery will be scanned. The diameter of the radial artery will be measured and recorded. | Other | All patients |
| Ulnar artery doppler ultrasonographyUltrasonography measurements will be performed with a linear probe before and after induction. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degrees with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the ulnar arter will be scanned. The blood fow of ulnar artery will be measured and recorded. | Other | All patients |
Primary outcome
change of the radial artery diameter according to sex, age, height, weight and body mass index
Time frame: 5 minutes prior to anesthesia induction
Ultrasonography measurements will be performed with a linear probe. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degree with a wrist pad. The Ultrasonography probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial artery will be scanned. The diameter of the radial artery will be measured and recorded.
2 secondary outcomes
correlation between Allen test and doppler ultrasonography.
Time frame: 5 minutes prior to anesthesia induction
change of the radial artery diameter according to sex, age, height, weight and body mass index after the induction
Time frame: 5 minutes following to anesthesia induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
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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.
Güniz Meyancı Köksal, Prof. principal investigator
Istanbul University Cerrahpasa Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allen test, Radial artery diameter measurement by ultrasonography and Ulnar artery doppler ultrasonography in people with Anesthesia and Ultrasonography, run by Istanbul University 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Sıla Akkuş (00905553044975, aysesilaakkus@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of the radial artery diameter according to sex, age, height, weight and body mass index (time frame: 5 minutes prior to anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2018.