General AnesthesiaNCT00859846
Ultrasound Guided Arterial Line Placement in Long Axis Versus Short Axis in Pediatric Patients
A study testing Arterial line placement in people with General Anesthesia, run by University of Oklahoma at 1 site in United States.
Trial summary
The use of ultrasound is becoming widespread to guide the placement of arterial lines for both vascular access and regional anesthesia in the field of anesthesia. Arterial line placement can be challenging, especially in the pediatric population. Read more about this study
- Who is it for?
- Ages 1 day to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Arterial line placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2009to 25 Sep 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 1 day to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The investigators will identify patients 0 to 14 years of age who are classified as ASA physical status ≤4 and scheduled to have surgery under general anesthesia
Who cannot join
- History of vasculitis, autoimmune disease, Reynauds phenomenon or disease
- History of no collateral perfusion
- The absence of an upper extremity artery to cannulate such as a bilateral amputee
- A child in DHS custody
- Infection at the site of insertion
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Oklahoma Health Sciences Center Deparment of Anesthesiology
Oklahoma City, Oklahoma, 73104
About this study
Official title: Comparison of Ultrasound Guided Arterial Line Placement in Long Axis Versus Short Axis in Pediatric Patients.
The use of ultrasound is becoming widespread to guide the placement of arterial lines for both vascular access and regional anesthesia in the field of anesthesia. Arterial line placement can be challenging, especially in the pediatric population. Frequently multiple attempts are required with relatively high failure rates. This can result in excessive needle punctures and extended OR times. A few studies have looked at the use of ultrasound to decrease OR time and increase success rates both in adult and pediatric populations. These studies compared the traditional palpation method with either short axis or long axis views of the vessel using ultrasound guidance. No study to date has compared short axis and long axis views for arterial line placement in either the pediatric or adult population. Our study compares success rates and OR times when long and short axis methods of arterial line insertion are employed in the pediatric population.
Read the detailed description
An Arterial line is an intraoperative monitor that is frequently placed in the pediatric population. Due to their smaller anatomy and more compliant skin, arterial lines can be more difficult to insert in the pediatric population than in adults. Additionally, lower perfusion pressure and larger subcutaneous adipose tissue can make pulse palpation more difficult. Ultrasound is a modality that can directly image the radial, ulnar, or brachial artery. Along with 2D ultrasound, doppler ultrasound can be utilized to confirm that an artery is not a vein. Once the vessel is identified, the vessel can be viewed in either the long or short access. The ultrasound beam is only 1 millimeter thick so a practitioner must stabilize the probe to view the vessel, especially in the long axis view. Once the artery is viewed in long axis, the needle can be directly visualized all the way into the vessel. Visualization of a guidewire or catheter in the vessel can confirm proper arterial access. In a short access ultrasound view, it is possible to see tissue movement and sometimes a hyperechoic (bright) dot which represents the needle. Tissue movement can help confirm the needle is immediately above the artery at all times. The advantage of the short axis view is that less precision is needed to hold and position the transducer than with the long axis view. The disadvantage of the short axis view is that the operator cannot see the tip of the angiocatheter as it enters the vessel. As a result, the proximal portion of the angiocatheter can be above the artery but the distal tip could be to the side of the artery.
- Conditions
- General Anesthesia
- Being tested
- Arterial line placement
- Keywords
- Arterial line, Ultrasound, Anesthesia, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial line placementProcedure or surgery
Also called Ultrasound guided (short vs Long axis)
The following measures will be collected and compared.
- Time (in seconds) required for successful placement of the arterial line. This is the time elapsed between either palpation or placement of ultrasound probe on the patient's wrist and the successful demonstration of arterial waveform on the anesthesia monitor.
- number of attempts, defined as forward advancements of needle, required to cannulate the artery.
- number of separate skin punctures.
- number of arteries into which entry is attempted.
| Study group | Role | What they receive |
|---|---|---|
| Long Axis arterial line placement | Experimental | Twenty four patients will undergo arterial line placements using long axis arterial line placement under ultrasound. Receives: Procedure: Arterial line placement |
| Short Axis arterial line placement | Experimental | Twenty four patients will undergo arterial line placements using short axis arterial line placement under ultrasound. Receives: Procedure: Arterial line placement |
| Palpation arterial line placement | Active comparator | Twenty four patients will undergo arterial line placements using Traditional palpation arterial line placement. Receives: Procedure: Arterial line placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using the long axis ultrasound view increases the success rate of arterial line insertions compared to using the short axis view.
Using the long axis ultrasound view increases the success rate of arterial line
Measured: 1.5 year
Secondary outcomes (1)
Using the short axis view, when successful, results in quicker insertion than when using the long axis view.
Using the short axis view, when successful, results in quicker insertion than when using the long axis view.
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study start17 Mar 2009
- Primary completion25 Sep 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto J de Armendi, MD, Principal investigator, Oklahoma University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859846
- Sponsor's protocol ID
- 2340
- Status last verified
- Oct 2018
- First submitted
- 9 Mar 2009
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Schwemmer U, Brederlau J. [Ultrasound techniques in anesthesiology--guided vascular access using sonography]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2006 Nov;41(11):740-9. doi: 10.1055/s-2006-958847. German.
PubMed 17151988Shiver 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 17079789
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided Arterial Line Placement in Long Axis Versus Short Axis in Pediatric Patients.
- ClinicalTrials.gov ID
- NCT00859846
- Acronym / sponsor ID
- 2340
- Conditions
- General Anesthesia
- Keywords
- Arterial line, Ultrasound, Anesthesia, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 17 Mar 2009 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 11 Mar 2009 (estimated)
- 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.
The use of ultrasound is becoming widespread to guide the placement of arterial lines for both vascular access and regional anesthesia in the field of anesthesia. Arterial line placement can be challenging, especially in the pediatric population. Frequently multiple attempts are required with relatively high failure rates. This can result in excessive needle punctures and extended OR times. A few studies have looked at the use of ultrasound to decrease OR time and increase success rates both in adult and pediatric populations. These studies compared the traditional palpation method with either short axis or long axis views of the vessel using ultrasound guidance. No study to date has compared short axis and long axis views for arterial line placement in either the pediatric or adult population. Our study compares success rates and OR times when long and short axis methods of arterial line insertion are employed in the pediatric population.
Detailed description
An Arterial line is an intraoperative monitor that is frequently placed in the pediatric population. Due to their smaller anatomy and more compliant skin, arterial lines can be more difficult to insert in the pediatric population than in adults. Additionally, lower perfusion pressure and larger subcutaneous adipose tissue can make pulse palpation more difficult. Ultrasound is a modality that can directly image the radial, ulnar, or brachial artery. Along with 2D ultrasound, doppler ultrasound can be utilized to confirm that an artery is not a vein. Once the vessel is identified, the vessel can be viewed in either the long or short access. The ultrasound beam is only 1 millimeter thick so a practitioner must stabilize the probe to view the vessel, especially in the long axis view. Once the artery is viewed in long axis, the needle can be directly visualized all the way into the vessel. Visualization of a guidewire or catheter in the vessel can confirm proper arterial access. In a short access ultrasound view, it is possible to see tissue movement and sometimes a hyperechoic (bright) dot which represents the needle. Tissue movement can help confirm the needle is immediately above the artery at all times. The advantage of the short axis view is that less precision is needed to hold and position the transducer than with the long axis view. The disadvantage of the short axis view is that the operator cannot see the tip of the angiocatheter as it enters the vessel. As a result, the proximal portion of the angiocatheter can be above the artery but the distal tip could be to the side of the artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long Axis arterial line placement | Experimental | Procedure: Arterial line placementTwenty four patients will undergo arterial line placements using long axis arterial line placement under ultrasound. |
| Short Axis arterial line placement | Experimental | Procedure: Arterial line placementTwenty four patients will undergo arterial line placements using short axis arterial line placement under ultrasound. |
| Palpation arterial line placement | Active comparator | Procedure: Arterial line placementTwenty four patients will undergo arterial line placements using Traditional palpation arterial line placement. |
Who may qualify
- Ages
- 1 day to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The investigators will identify patients 0 to 14 years of age who are classified as ASA physical status ≤4 and scheduled to have surgery under general anesthesia
Key exclusion criteria (6 listed)
- History of vasculitis, autoimmune disease, Reynauds phenomenon or disease
- History of no collateral perfusion
- The absence of an upper extremity artery to cannulate such as a bilateral amputee
- A child in DHS custody
- Infection at the site of insertion
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 |
|---|---|---|
| Arterial line placementAlso: Ultrasound guided (short vs Long axis)The following measures will be collected and compared. 1. Time (in seconds) required for successful placement of the arterial line. This is the time elapsed between either palpation or placement of ultrasound probe on the patient's wrist and the successful demonstration of arterial waveform on the anesthesia monitor. 2. number of attempts, defined as forward advancements of needle, required to cannulate the artery. 3. number of separate skin punctures. 4. number of arteries into which entry is attempted. | Procedure or surgery | Long Axis arterial line placement, Palpation arterial line placement, Short Axis arterial line placement |
Primary outcome
Using the long axis ultrasound view increases the success rate of arterial line insertions compared to using the short axis view.
Time frame: 1.5 year
Using the long axis ultrasound view increases the success rate of arterial line
1 secondary outcome
Using the short axis view, when successful, results in quicker insertion than when using the long axis view.
Time frame: 1.5 year
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 12 Oct 2018.
- Background: PubMed 17151988Schwemmer U, Brederlau J. [Ultrasound techniques in anesthesiology--guided vascular access using sonography]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2006 Nov;41(11):740-9. doi: 10.1055/s-2006-958847. German.
- 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.
- Individual participant dataSharing planned: No
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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.
Alberto J de Armendi, MD principal investigator
Oklahoma University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial line placement in people with General Anesthesia, run by University of Oklahoma at 1 site in United States.
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 1 inclusion and 6 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 12 Oct 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 United States. 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?
Using the long axis ultrasound view increases the success rate of arterial line insertions compared to using the short axis view. (time frame: 1.5 year). 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 NCT00859846, which also lists 2 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 12 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.