Vascular Access ComplicationNCT03326739
Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns
A study testing Arterial Line Placement in people with Vascular Access Complication, run by Temple University at 1 site in United States.
Trial summary
Critically ill patients in the emergency department commonly require arterial line placement for continuous direct blood pressure monitoring, frequent arterial blood gas sampling, and frequent blood sampling. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Access Complication
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 31 Dec 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients requiring arterial line placement.
Who cannot join
- Adults Unable to Consent
- Members of Vulnerable Populations
Trial locations and contacts
1 site in 1 country.
United States1 site
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140
About this study
Critically ill patients in the emergency department commonly require arterial line placement for continuous direct blood pressure monitoring, frequent arterial blood gas sampling, and frequent blood sampling. Trans-radial catheterization has been shown to reduce access site complications and increase patient comfort compared to trans-femoral access. Radial artery access on the first attempt is optimal; attempts at reentry delay care and increase the risk of vascular spasm, hematoma, infection, neurovascular injury, and pain. The traditional pulse palpation method of radial artery cannulation can be challenging, especially in patients with weak pulses (i.e. morbidly obese or hypotensive individuals).
A review of literature suggests that ultrasound guided trans-radial catheterization compared to standard pulse palpation reduces access time and increases rate of first-entry success when performed by physicians trained in ultrasound. Thus, complications ascribed to reentry are prevented and timely care is provided.
To the investigator's knowledge, only one other prospective study has been conducted to assess the utility of ultrasound guided radial artery cannulation in the emergency department. Due to the paucity of literature to support the use of ultrasound guided trans-radial catheterization in critically ill patients, the study will aim to provide further data on the topic. Both techniques are considered standard of care.
Read the detailed description
Patients presenting to the Emergency Department 18 years old or greater, who do not belong to a vulnerable group, requiring arterial line placement will be included in this trial. The investigators will randomize each patient into LM vs US. Data collected will include number of attempts, success rate, and time for procedure to be completed. PGY-1 residents will perform the arterial line placement.
- Conditions
- Vascular Access Complication
- Being tested
- Arterial Line Placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Line PlacementProcedure or surgery
arterial line placement
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided A-Line Placement | Active comparator | Patients in this group will have ultrasound guided arterial line placement. Receives: Procedure: Arterial Line Placement |
| Landmark Guided A-line Placement | Active comparator | Patients in this group will have landmark guided 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.
Superiority of Method of arterial line placement
Number of attempts until successful cannulation.
Measured: 1 day
Secondary outcomes (1)
Success of method
Completion of arterial line placement after three attempts
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan C Gibbons, MD, Principal investigator, Lewis Katz School of Medicine at Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326739
- Sponsor's protocol ID
- 24642
- Status last verified
- Jan 2020
- First submitted
- 17 Oct 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns
- ClinicalTrials.gov ID
- NCT03326739
- Acronym / sponsor ID
- 24642
- Conditions
- Vascular Access Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 31 Oct 2017 (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.
Critically ill patients in the emergency department commonly require arterial line placement for continuous direct blood pressure monitoring, frequent arterial blood gas sampling, and frequent blood sampling. Trans-radial catheterization has been shown to reduce access site complications and increase patient comfort compared to trans-femoral access. Radial artery access on the first attempt is optimal; attempts at reentry delay care and increase the risk of vascular spasm, hematoma, infection, neurovascular injury, and pain. The traditional pulse palpation method of radial artery cannulation can be challenging, especially in patients with weak pulses (i.e. morbidly obese or hypotensive individuals).
A review of literature suggests that ultrasound guided trans-radial catheterization compared to standard pulse palpation reduces access time and increases rate of first-entry success when performed by physicians trained in ultrasound. Thus, complications ascribed to reentry are prevented and timely care is provided.
To the investigator's knowledge, only one other prospective study has been conducted to assess the utility of ultrasound guided radial artery cannulation in the emergency department. Due to the paucity of literature to support the use of ultrasound guided trans-radial catheterization in critically ill patients, the study will aim to provide further data on the topic. Both techniques are considered standard of care.
Detailed description
Patients presenting to the Emergency Department 18 years old or greater, who do not belong to a vulnerable group, requiring arterial line placement will be included in this trial. The investigators will randomize each patient into LM vs US. Data collected will include number of attempts, success rate, and time for procedure to be completed. PGY-1 residents will perform the arterial line placement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided A-Line Placement | Active comparator | Procedure: Arterial Line PlacementPatients in this group will have ultrasound guided arterial line placement. |
| Landmark Guided A-line Placement | Active comparator | Procedure: Arterial Line PlacementPatients in this group will have landmark guided arterial line placement. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring arterial line placement.
Key exclusion criteria (2 listed)
- Adults Unable to Consent
- Members of Vulnerable Populations
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 Placementarterial line placement | Procedure or surgery | Landmark Guided A-line Placement, Ultrasound Guided A-Line Placement |
Primary outcome
Superiority of Method of arterial line placement
Time frame: 1 day
Number of attempts until successful cannulation.
1 secondary outcome
Success of method
Time frame: 1 day
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 22 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Ryan C Gibbons, MD principal investigator
Lewis Katz School of Medicine at Temple University
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 Vascular Access Complication, run by Temple University 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 2 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 22 Jan 2020. 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?
Superiority of Method of arterial line placement (time frame: 1 day). 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 22 Jan 2020.