AnesthesiaNCT01276171
Ultrasound-image Guided Versus Doppler Guided Versus Palpation Technique for Arterial Cannulation in Adults
A study testing Ultrasound, Doppler and Palpation in people with Anesthesia, run by University of Iowa at 1 site in United States.
Trial summary
Radial arterial cannulation is a common invasive procedure for real-time measurement of arterial blood pressure. Placement of the arterial catheter using conventional palpation is often relatively easy and quick, but this is not always true. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Ultrasound, Doppler and Palpation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 749 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Main OR patients at UIHC who require arterial catheter placement for surgery
Who cannot join
- The patients who will be excluded from the study include those who have had arterial cannulation in the previous month, infections at site of insertion, and AV shunts in upper extremity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Radial arterial cannulation is a common invasive procedure for real-time measurement of arterial blood pressure. Placement of the arterial catheter using conventional palpation is often relatively easy and quick, but this is not always true. A relatively new method for direct visualization of the artery is the use of two-dimensional ultrasound. This technique allows cannulation of the artery to take place under real-time visualization and may increase the success rate of first time pass of the needle. Another technique utilizing Doppler has also proven to be effective in cannulating the radial artery. This technique utilizes changes in acoustic pitch as the probe passes directly over the artery. The primary objective of this study is to compare the first attempt success rate for radial artery cannulation among the palpation, Doppler and U/S guided technique when applied by trainees. Secondary outcomes include: success rate within 5 minutes, successful, number of attempts required, and correlation between success rate and operator experience for successful cannulation of the radial artery.
Read the detailed description
Radial artery cannulation is a common invasive procedure in the operating room, intensive care unit and emergency department. It allows continuous hemodynamic monitoring and repeated arterial blood sampling. Although severe complications are rare, successful radial artery cannulation can be technically challenging, particularly in hypotensive patients and those with vascular disease. Multiple unsuccessful attempts at arterial cannulation increase patient discomfort, delay timely care and may also contribute to adverse events such as arterial spasm or local hematoma.
The radial artery is traditionally located by palpation. A number of techniques to aid radial artery localization have been described. Doppler-assisted radial arterial cannulation was first described in 1976. Several case reports suggest that Doppler can be helpful in patients with difficult arterial access. More recently, ultrasound-guided radial artery cannulation has been described. In a recent meta-analysis of four randomized controlled trials, ultrasound increased the rate of cannulation on the first attempt by 71% compared with palpation. However, two of the studies were of children and all four were small, with 30-152 participants (311 in total), making the generalizability of these results to adult patients uncertain. Furthermore, variation in the training and experience of the operators was evident within one of the studies.
Accordingly, the aim of this study is to compare three different radial arterial cannulation techniques in adult surgical patients when performed by anesthesia residents: Doppler; palpation; and ultrasound. We think that ultrasound would have a higher rate of cannulation on the first attempt compared with other techniques.
- Conditions
- Anesthesia
- Being tested
- Ultrasound, Doppler, Palpation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Participants will place arterial line using ultrasound technique
DopplerProcedure or surgery
Participants will place arterial line using doppler technique
PalpationProcedure or surgery
Participants will place arterial line using Palpation technique
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Active comparator | Participants will place arterial line using ultrasound technique Receives: Procedure: Ultrasound |
| Doppler | Active comparator | Participants will place arterial line using doppler technique Receives: Procedure: Doppler |
| Palpation | Active comparator | Participants will place arterial line using palpation technique Receives: Procedure: Palpation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Attempt Success Rate With 3 Different Technique
The primary objective of this study is to compare the first attempt success rate for radial artery cannulation between the palpation, Doppler and U/S guided technique when applied by anesthesia trainees. Secondary outcomes include: success rate within 5 minutes, time to successful cannulation compared with three different techniques.
Measured: 5 minutes
Secondary outcomes (2)
Time to Successful Cannulation
Measured: 5 minutes
Total Success Rate
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startFeb 2010
- Primary completionDec 2011
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 749 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenichi Ueda, University of Iowa
- Investigators
- Kenichi Ueda, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276171
- Sponsor's protocol ID
- 201001776
- Status last verified
- Apr 2017
- First submitted
- 11 Jan 2011
- Last updated
- 26 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: We are not planning on sharing IPD.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-image Guided Versus Doppler Guided Versus Palpation Technique for Arterial Cannulation in Adults
- ClinicalTrials.gov ID
- NCT01276171
- Acronym / sponsor ID
- 201001776
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 749 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Posted 26 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radial arterial cannulation is a common invasive procedure for real-time measurement of arterial blood pressure. Placement of the arterial catheter using conventional palpation is often relatively easy and quick, but this is not always true. A relatively new method for direct visualization of the artery is the use of two-dimensional ultrasound. This technique allows cannulation of the artery to take place under real-time visualization and may increase the success rate of first time pass of the needle. Another technique utilizing Doppler has also proven to be effective in cannulating the radial artery. This technique utilizes changes in acoustic pitch as the probe passes directly over the artery. The primary objective of this study is to compare the first attempt success rate for radial artery cannulation among the palpation, Doppler and U/S guided technique when applied by trainees. Secondary outcomes include: success rate within 5 minutes, successful, number of attempts required, and correlation between success rate and operator experience for successful cannulation of the radial artery.
Detailed description
Radial artery cannulation is a common invasive procedure in the operating room, intensive care unit and emergency department. It allows continuous hemodynamic monitoring and repeated arterial blood sampling. Although severe complications are rare, successful radial artery cannulation can be technically challenging, particularly in hypotensive patients and those with vascular disease. Multiple unsuccessful attempts at arterial cannulation increase patient discomfort, delay timely care and may also contribute to adverse events such as arterial spasm or local hematoma.
The radial artery is traditionally located by palpation. A number of techniques to aid radial artery localization have been described. Doppler-assisted radial arterial cannulation was first described in 1976. Several case reports suggest that Doppler can be helpful in patients with difficult arterial access. More recently, ultrasound-guided radial artery cannulation has been described. In a recent meta-analysis of four randomized controlled trials, ultrasound increased the rate of cannulation on the first attempt by 71% compared with palpation. However, two of the studies were of children and all four were small, with 30-152 participants (311 in total), making the generalizability of these results to adult patients uncertain. Furthermore, variation in the training and experience of the operators was evident within one of the studies.
Accordingly, the aim of this study is to compare three different radial arterial cannulation techniques in adult surgical patients when performed by anesthesia residents: Doppler; palpation; and ultrasound. We think that ultrasound would have a higher rate of cannulation on the first attempt compared with other techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Active comparator | Procedure: UltrasoundParticipants will place arterial line using ultrasound technique |
| Doppler | Active comparator | Procedure: DopplerParticipants will place arterial line using doppler technique |
| Palpation | Active comparator | Procedure: PalpationParticipants will place arterial line using palpation technique |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Main OR patients at UIHC who require arterial catheter placement for surgery
Key exclusion criteria (1 listed)
- The patients who will be excluded from the study include those who have had arterial cannulation in the previous month, infections at site of insertion, and AV shunts in upper extremity.
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 |
|---|---|---|
| UltrasoundParticipants will place arterial line using ultrasound technique | Procedure or surgery | Ultrasound |
| DopplerParticipants will place arterial line using doppler technique | Procedure or surgery | Doppler |
| PalpationParticipants will place arterial line using Palpation technique | Procedure or surgery | Palpation |
Primary outcome
First Attempt Success Rate With 3 Different Technique
Time frame: 5 minutes
The primary objective of this study is to compare the first attempt success rate for radial artery cannulation between the palpation, Doppler and U/S guided technique when applied by anesthesia trainees. Secondary outcomes include: success rate within 5 minutes, time to successful cannulation compared with three different techniques.
2 secondary outcomes
Time to Successful Cannulation
Time frame: 5 minutes
Total Success Rate
Time frame: 5 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We are not planning on sharing IPD.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Kenichi Ueda, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound, Doppler and Palpation in people with Anesthesia, run by University of Iowa 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 1 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 26 Jun 2017. 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?
Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
First Attempt Success Rate With 3 Different Technique (time frame: 5 minutes). 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 26 Jun 2017.